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TORONTO, ON--(Marketwired - October 24, 2016) - Join industry expert Svetlana Kolchinsky, Direction of Project Operations at BioTelemetry Research (Cardiocore & VirtualScopics) on Thursday, November 3, 2016 at 11am EDT (3pm GMT/UK), as she outlines what it takes to manage multi-protocol programs and deliver consistent results. Multi-protocol programs: Are you prepared to take on the challenge of complex data acquisition parameters? Every project has a unique set of requirements that needs to be reviewed and approached carefully for successful and timely execution. For example, the study needs properly equipped clinical sites, trained technicians, experienced readers to accurately analyze the incoming data, and a proficient team ready to lead the way. A comprehensive core lab, which can efficiently execute these tasks and meet study milestones, can be a clinical lead's greatest asset. To a team of project managers at BioTelemetry Research, this is an exciting task of orchestrating a set of steps that leads to a cascade of events, which results in a symphony of data that brings joy to our customers and becomes part of a much greater production. During the webinar Kolchinsky will share operational best practices, how to successfully reduce risks, cost savings, and the benefits of partnering with a core lab, which include: Register today to discover how partnering with BioTelemetry Research ensures consistent and experienced program managers with extensive knowledge, that leads to a successful study execution. For more information or to register for this complimentary event, visit: Managing Multi-Protocol Programs & Building Efficient Partnerships Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit: http://xtalks.com


News Article | February 22, 2017
Site: globenewswire.com

MALVERN, Pa., Feb. 22, 2017 (GLOBE NEWSWIRE) -- BioTelemetry, Inc. (NASDAQ:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the fourth quarter and full year ended December 31, 2016. Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, Inc., commented: “2016 was an outstanding year for BioTelemetry.  As a result of the effective execution of our strategic initiatives, we recorded record revenue, earnings and adjusted EBITDA, achieving the high-end of our fourth quarter guidance.  Additionally, we continued our tradition of innovation and completed three acquisitions, gaining entree into an exciting, new and large market opportunity.  Moreover, we serviced approximately 600,000 patients in 2016 alone, representing an almost 8% increase versus the prior year, with our mobile cardiac telemetry (“MCT”) volume experiencing double-digit growth.  We also received a positive coverage decision from Anthem, the largest health insurer in the nation, for use of MCT for certain patients.  Finally, we obtained FDA clearance on our next generation MCT device, setting the stage for sustained volume growth well into the future. “Looking forward, we are excited about our expansion into digital population health management (“PHM”) through our acquisition of Telcare.  We believe PHM represents a large market opportunity, and we are uniquely positioned to assume a leadership position.  On the cost side, we made great progress in gaining efficiencies in 2016 and, we will continue to look for additional opportunities.  We enter 2017 confident it will be another year of strong financial results and operational successes.” Revenue for the fourth quarter 2016 was $54.0 million compared to $46.8 million for the fourth quarter 2015, reflecting an increase of $7.2 million, or 15.4%.  Healthcare revenue increased $3.0 million due to increased patient volumes and higher patient pricing due to a favorable product mix as well as higher MCT Medicare pricing.  Research revenue increased $3.4 million due to the acquisition of VirtualScopics during the second quarter.  Technology revenue increased $0.9 million due to Telcare as well as sales of our ePatch Holter. Gross profit for the fourth quarter 2016 increased to $33.0 million, or 61.2% of revenue, compared to $28.3 million, or 60.4% of revenue, for the fourth quarter 2015.  The increase in gross margin percentage was due to the impact of higher Healthcare pricing, volume efficiencies and cost reductions partially offset by the impact of the acquisitions, which carry lower margins than our existing business. On a GAAP basis, operating expense for the fourth quarter 2016 was $29.6 million, compared to $24.8 million for the fourth quarter 2015.  On an adjusted basis1, operating expense for the fourth quarter 2016 was $25.5 million compared to $23.2 million for the fourth quarter 2015, an increase of $2.3 million, or 10.1%.  The adjusted operating expense for the fourth quarter 2016 excludes $2.8 million of other charges primarily related to patent litigation and the integration of the current year acquisitions and $1.3 million for a one-time performance bonus paid to a third party in the form of stock-based compensation.  The adjusted operating expense for the fourth quarter 2015 excludes $1.6 million primarily related to patent litigation.  The increase in adjusted expense was driven by the addition of $2.3 million related to our acquired companies, a $0.8 million increase in bad debt expense and $0.1 million of additional consulting expense related to ongoing product development.  These increases were partially offset by a $0.9 million reduction in headcount related expenses. Interest and other loss, net was $0.6 million for the fourth quarter 2016 compared to $0.4 million for the fourth quarter 2015.  The increase was due to losses related to the Company’s equity method investment in Wellbridge Health and increased borrowings under the revolving credit facility. During the fourth quarter 2016, the Company released a tax valuation allowance on its net deferred tax assets.  Over time, the Company had recorded deferred tax assets, but, due to the Company’s history of losses, management established a valuation allowance to offset these assets.  Management has now determined that there is sufficient evidence to conclude that it is more-likely-than-not that the Company will realize these benefits, and, as a result, the Company reduced its valuation allowance accordingly.  This reduction resulted in a one-time income tax benefit in the fourth quarter 2016 Consolidated Statement of Operations in the amount of $37.6 million.  Without a valuation allowance in place, for GAAP financial reporting purposes, the Company expects its 2017 tax rate to be in the range of 38% to 39%.  However, due to the utilization of net operating loss carryforwards, the Company expects 2017 actual cash tax payments to remain in the 3% to 5% range. On a GAAP basis, net income for the fourth quarter 2016 was $40.4 million, or $1.30 per diluted share, compared to net income of $2.8 million, or $0.10 per diluted share, for the fourth quarter 2015.  On an adjusted basis1, net income for the fourth quarter 2016 was $7.0 million, or $0.23 per diluted share.  This compares to adjusted net income of $4.4 million, or $0.15 per diluted share, for the fourth quarter 2015.  Adjusted net income for the fourth quarter 2016 excludes the $37.6 million income tax benefit related to the valuation allowance release, $2.8 million of other charges primarily related to patent litigation and the integration of the current year acquisitions and $1.3 million for a one-time performance bonus paid to a third party in the form of stock-based compensation.  Adjusted net income for the fourth quarter 2015 excludes $1.6 million primarily related to patent litigation. As of December 31, 2016, total cash was $23.1 million compared to $19.0 million as of December 31, 2015, a $4.1 million increase.  During 2016, the Company used $25.0 million for acquisitions and $10.9 million for capital expenditures, primarily medical devices while generating $38.9 million of cash from operations.  In addition, the Company borrowed $14.5 million from our revolving credit facility during the second quarter 2016, repaying $11.5 million of this balance during the fourth quarter 2016.  Consolidated days sales outstanding decreased to 45 days as of December 31, 2016, down from 47 days as of December 31, 2015. As of December 31, 2016, the Company had net indebtedness of $2.3 million, comprised of indebtedness of $25.4 million and cash of $23.1 million. 1 The Company believes that providing non-GAAP financial measures offers a meaningful representation of the Company’s performance as they exclude expenses that are not necessary to support the Company’s ongoing business.  Please refer to the Company’s “Reconciliation of Non-GAAP Financial Measures” and “Use of Non-GAAP Financial Measures” in this release for additional information. Conference Call        BioTelemetry, Inc. will host an earnings conference call on Wednesday, February 22, 2017 at 5:00 PM Eastern Time.  The call will be simultaneously webcast on the investor information page of our website, www.gobio.com.  The call will be archived on our website for two weeks. About BioTelemetry BioTelemetry, Inc., formerly known as CardioNet, Inc., is the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care.  The Company currently provides cardiac monitoring services, original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized cardiac core laboratory services.  More information can be found at www.gobio.com. Cautionary Statement Regarding Forward-Looking Statements This document includes certain forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements may be identified by words such as “expect,” “anticipate,” “estimate,” “intend,” “plan,” “believe,” “promises” and other words and terms of similar meaning.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including important factors that could delay, divert, or change any of these expectations, and could cause actual outcomes and results to differ materially from current expectations.  These factors include, among other things, our ability to successfully integrate acquisitions into our business and the effect such acquisitions will have on our results of operation, effectiveness of our cost savings initiatives, relationships with our government and commercial payors, changes to insurance coverage and reimbursement levels for our products, the success of our sales and marketing initiatives, our ability to attract and retain talented executive management and sales personnel, our ability to identify acquisition candidates, acquire them on attractive terms and integrate their operations into our business, the commercialization of new products, market factors, internal research and development initiatives, partnered research and development initiatives, competitive product development, changes in governmental regulations and legislation, the continued consolidation of payors, acceptance of our new products and services, patent protection, adverse regulatory action, and litigation success.  For further details and a discussion of these and other risks and uncertainties, please see our public filings with the Securities and Exchange Commission, including our latest periodic reports on Form 10-K and 10-Q.  We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Reconciliation of Non-GAAP Financial Measures (In Thousands, Except Per Share Amounts) (a) In the fourth quarter 2016, the Company incurred $2.8 million of other charges primarily due to patent litigation and the acquisitions completed in the current year.  In the fourth quarter 2015, the Company incurred $1.6 million of other charges primarily related to patent litigation. (b) In the fourth quarter 2016, the Company incurred $1.3 million for a one-time performance bonus paid to a third party in the form of stock-based compensation.  This is a nonrecurring expense for the Company and is the only time in the Company’s history when such a bonus was awarded.  There are no additional agreements outstanding of this nature. (c) During the fourth quarter 2016, the Company released a tax valuation allowance on its net deferred tax assets.  This release resulted in a one-time income tax benefit in the fourth quarter 2016 Consolidated Statement of Operations in the amount of $37.6 million.  This benefit is nonrecurring and not indicative of the Company’s ongoing results or future tax position.    Reconciliation of Non-GAAP Financial Measures (In Thousands, Except Per Share Amounts) (a) In 2016, the Company incurred $8.6 million other charges primarily due to patent litigation and the acquisitions completed in the current year.  In 2015, the Company incurred $6.1 million of other charges primarily due to patent litigation and other legal fees. (b) In 2016, the Company incurred $1.3 million for a one-time performance bonus paid to a third party in the form of stock-based compensation.  This is a nonrecurring expense for the Company and is the only time in the Company’s history when such a bonus was awarded.  There are no additional agreements outstanding of this nature. (c) During 2016, the Company released a tax valuation allowance on its net deferred tax assets.  This reduction resulted in a one-time income tax benefit in the 2016 Consolidated Statement of Operations in the amount of $37.6 million.  This benefit is nonrecurring and not indicative of the Company’s ongoing results or future tax position. Use of Non-GAAP Financial Measures In addition to the results prepared in accordance with generally accepted accounting principles in the United States, or GAAP, this press release also includes certain financial measures which have been adjusted and are not in accordance with generally accepted accounting principles (“Non-GAAP financial measures”).  These Non-GAAP financial measures include adjusted income from operations, adjusted net income, adjusted net income per diluted share and adjusted EBITDA.  In accordance with Regulation G of the Securities and Exchange Commission, the Company has provided a reconciliation of these Non-GAAP financial measures with the most directly comparable financial measure calculated in accordance with GAAP. These Non-GAAP financial measures are not intended to replace GAAP financial measures.  They are presented as supplemental measures of our performance in an effort to provide our stakeholders better visibility into the Company’s ongoing operating results and to allow for comparability to prior periods as well as to other companies’ results.  Management uses these Non-GAAP financial measures to assess the financial health of the Company’s ongoing operating performance.  Management encourages our stakeholders to consider all of our financial measures and to not rely on any single financial measure to evaluate our performance. Adjusted income from operations, adjusted net income and adjusted net income per diluted share exclude Other charges, a one-time performance bonus paid to a third party in the form of stock-based compensation and the release of the Company’s valuation allowance.  By excluding expenses that are considered not necessary to support the ongoing business or which are nonrecurring in nature, the Company believes that these Non-GAAP financial measures offer a meaningful representation of the Company’s ongoing operating performance.  Patent litigation expense is a component of Other charges.  We view patent litigation as an extreme measure not typically required in our industry to protect a company’s intellectual property and which has not been common practice for the Company.  The Company commenced patent litigation proceedings after the Company uncovered specific evidence of four distinct cases of misappropriation and infringement.  The Company can choose to resolve the outstanding matters and terminate the expense at any time.  Also included in Other charges are transaction related expenses which include integration costs, primarily professional fees and severance, which are not part of the ongoing operations, and therefore, not reflective of the Company’s core operations.  The Company also excluded a one-time performance bonus paid to a third party in the form of stock-based compensation.  This is the first time in the Company’s history that such a bonus was offered and issued and the expense is nonrecurring.  There are no additional agreements outstanding of this nature.  Finally, the Company excluded the nonrecurring benefit from the release of its tax valuation allowance from its non-GAAP financial measures. In addition to adjusted income from operations, adjusted net income and adjusted net income per diluted share, we also present adjusted EBITDA.  This Non-GAAP financial measure excludes income taxes, interest, Other charges, other one-time items such as the tax valuation allowance release, depreciation and amortization and stock compensation expense.  EBITDA is a widely accepted financial measure which we believe our stakeholders use to compare our ongoing financial performance to that of other companies.  Adjusting our EBITDA for Other charges and other one-time items is a meaningful financial measure as we believe it is an indication of our ongoing operations.  In addition, we also add back stock compensation expense because it is non-cash in nature.  Other companies in our industry may calculate adjusted EBITDA in a different manner.


News Article | November 2, 2016
Site: globenewswire.com

MALVERN, Pa., Nov. 02, 2016 (GLOBE NEWSWIRE) -- BioTelemetry, Inc. (NASDAQ:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the third quarter ended September 30, 2016. Joseph H. Capper, President and Chief Executive Officer of BioTelemetry, Inc., commented: “With our strong third quarter results, we delivered our seventeenth consecutive quarter of year over year revenue growth and our seventh consecutive quarter of year over year net income growth.  Our commitment to our core operating principles continues to deliver outstanding results, as evidenced by our 40% adjusted EBITDA growth.  Our top line momentum, with 22% growth, was driven by the success of our sales strategy to be the single source provider of cardiac monitoring solutions.  As a result, we continue to grow substantially faster than the market, posting 9% patient volume growth, highlighted by double digit MCT growth.  Additionally, our second quarter acquisitions had a positive impact on both our top and bottom lines. “BioTelemetry is on track to deliver record results for 2016, and we expect to achieve the higher end of our adjusted EBITDA guidance of $44 to $46 million.  Looking forward to 2017, we expect the Company’s growth to continue to outpace the cardiac monitoring industry.  This will be driven, in part, by the expansion of our unmatched product portfolio with the upcoming launch of our next generation device, the MCOTTM Patch, and by maximizing the opportunity to now service certain Anthem patients with MCT.  We are also uniquely positioned to capitalize on other opportunities to use our technology to improve patient care and lower costs.  With our proven strategy and strong performance, we are confident that our growth will continue into 2017.” Revenue for the third quarter 2016 was $53.1 million compared to $43.5 million for the third quarter 2015, reflecting an increase of $9.6 million, or 22.0%.  Healthcare revenue increased $4.7 million due to increased patient volumes and higher patient pricing due to a favorable product mix as well as higher MCT Medicare pricing.  Research revenue increased $4.9 million, due to the acquisition of VirtualScopics during the second quarter. Gross profit for the third quarter 2016 increased to $32.9 million, or 61.9% of revenue, compared to $26.3 million, or 60.6% of revenue, for the third quarter 2015.  The increase in gross margin percentage was due to Healthcare volume efficiencies, higher Healthcare pricing as well as reduced costs related to shipping and device communications.  These increases were partially offset by the impact of our acquisitions, which caused a shift in our revenue mix toward Research which carries a lower margin than our Healthcare business. On a GAAP basis, operating expense for the third quarter 2016 was $27.9 million, compared to $23.3 million for the second quarter 2015.  On an adjusted basis1, operating expense for the third quarter 2016 was $25.5 million compared to $21.9 million for the third quarter 2015.  The adjusted operating expense excludes $2.4 million of other charges for the third quarter 2016 primarily related to patent litigation and the integration of the second quarter acquisitions and $1.4 million for the third quarter 2015 primarily related to patent litigation. The increase in adjusted expense was driven by the addition of $2.0 million related to our acquired companies, a $1.0 million increase in employee related expense, a $0.3 million increase in bad debt expense and $0.3 million of additional consulting expense primarily related to ongoing product development. Interest and other loss, net was $0.6 million for the third quarter 2016 compared to $0.4 million for the third quarter 2015.  The increase was primarily due to higher interest expense stemming from borrowings under the revolving credit facility. On a GAAP basis, net income for the third quarter 2016 was $4.1 million, or $0.14 per diluted share, compared to net income of $2.5 million, or $0.08 per diluted share, for the third quarter 2015.  Excluding the $2.4 million of other charges1, adjusted net income for the third quarter 2016 was $6.5 million, or $0.21 per diluted share.  This compares to adjusted net income of $3.9 million, or $0.13 per diluted share, for the third quarter 2015, which excludes the impact of $1.4 million of other charges. As of September 30, 2016, total cash was $32.3 million, an increase of $6.8 million compared to June 30, 2016.  During the quarter ended September 30, 2016, the Company generated $8.9 million of cash from operations.  In addition, the Company used $2.8 million of cash during the quarter for capital expenditures, primarily medical devices.  Consolidated days sales outstanding decreased to 48 days as of September 30, 2016, down from 49 days as of June 30, 2016. As of September 30, 2016, the Company had total indebtedness of $37.4 million.  On October 11, 2016, the Company repaid $11.5 million of the outstanding borrowings under the revolving credit facility. ______________________________________ 1 The Company believes that its adjusted financial results, which exclude Other charges, offer a meaningful representation of the Company’s performance as they exclude expenses that are not necessary to support the Company’s ongoing business. Conference Call  BioTelemetry, Inc. will host an earnings conference call on Wednesday, November 2, 2016 at 5:00 PM Eastern Time.  The call will be simultaneously webcast on the investor information page of our website, www.gobio.com.  The call will be archived on our website for two weeks. About BioTelemetry BioTelemetry, Inc., formerly known as CardioNet, Inc., is the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care.  The Company currently provides cardiac monitoring services, original equipment manufacturing with a primary focus on cardiac monitoring devices and centralized cardiac core laboratory services.  More information can be found at www.gobio.com. Cautionary Statement Regarding Forward-Looking Statements This document includes certain forward-looking statements within the meaning of the “Safe Harbor” provisions of the Private Securities Litigation Reform Act of 1995.  These statements may be identified by words such as “expect,” “anticipate,” “estimate,” “intend,” “plan,” “believe,” “promises” and other words and terms of similar meaning.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including important factors that could delay, divert, or change any of these expectations, and could cause actual outcomes and results to differ materially from current expectations.  These factors include, among other things, our ability to successfully integrate acquisitions into our business and the effect such acquisitions will have on our results of operation, effectiveness of our cost savings initiatives, relationships with our government and commercial payors, changes to insurance coverage and reimbursement levels for our products, the success of our sales and marketing initiatives, our ability to attract and retain talented executive management and sales personnel, our ability to identify acquisition candidates, acquire them on attractive terms and integrate their operations into our business, the commercialization of new products, market factors, internal research and development initiatives, partnered research and development initiatives, competitive product development, changes in governmental regulations and legislation, the continued consolidation of payors, acceptance of our new products and services, patent protection, adverse regulatory action, and litigation success.  For further details and a discussion of these and other risks and uncertainties, please see our public filings with the Securities and Exchange Commission, including our latest periodic reports on Form 10-K and 10-Q.  We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Reconciliation of Non-GAAP Financial Measures (In Thousands, Except Per Share Amounts) In accordance with Regulation G of the Securities and Exchange Commission, the table set forth below reconciles certain financial measures used in this press release that were not calculated in accordance with generally accepted accounting principles, or GAAP, with the most directly comparable financial measure calculated in accordance with GAAP.  The Company believes that its adjusted financial results, which exclude Other charges, offer a meaningful representation of the Company’s performance as they exclude expenses that are not necessary to support the Company’s ongoing business. (a) In the third quarter 2016, the Company incurred $2.4 million of other charges primarily due to patent litigation and the acquisitions completed in the second quarter.  In the third quarter 2015, the Company incurred $1.4 million of other charges primarily related to patent litigation. Reconciliation of Non-GAAP Financial Measures (In Thousands, Except Per Share Amounts) In accordance with Regulation G of the Securities and Exchange Commission, the table set forth below reconciles certain financial measures used in this press release that were not calculated in accordance with generally accepted accounting principles, or GAAP, with the most directly comparable financial measure calculated in accordance with GAAP.  The Company believes that its adjusted financial results, which exclude Other charges, offer a meaningful representation of the Company’s performance as they exclude expenses that are not necessary to support the Company’s ongoing business. (a) In the first three quarters of 2016, the Company incurred $5.8 million other charges primarily due to patent litigation and the acquisitions completed in the second quarter.  In the first three quarters of 2015, the Company incurred $4.5 million of other charges primarily due to patent litigation as well as costs related to the integration of the 2014 acquisitions.


Turkbey B.,U.S. National Cancer Institute | Merino M.J.,U.S. National Institutes of Health | Gallardo E.C.,U.S. National Institutes of Health | Gallardo E.C.,Image science Institute | And 11 more authors.
Journal of Magnetic Resonance Imaging | Year: 2014

Purpose To compare utility of T2-weighted (T2W) MRI and diffusion-weighted MRI (DWI-MRI) obtained with and without an endorectal coil at 3 Tesla (T) for localizing prostate cancer. Materials and Methods This Institutional Review Board-approved study included 20 patients (median prostate-specific antigen, 8.4 ng/mL). Patients underwent consecutive prostate MRIs at 3T, first with a surface coil alone, then with combination of surface, endorectal coils (dual coil) followed by robotic assisted radical prostatectomy. Lesions were mapped at time of acquisition on dual-coil T2W, DWI-MRI. To avoid bias, 6 months later nonendorectal coil T2W, DWI-MRI were mapped. Both MRI evaluations were performed by two readers blinded to pathology with differences resolved by consensus. A lesion-based correlation with whole-mount histopathology was performed. Results At histopathology 51 cancer foci were present ranging in size from 2 to 60 mm the sensitivity of the endorectal dual-coil, nonendorectal coil MRIs were 0.76, 0.45, respectively. PPVs for endorectal dual-coil, nonendorectal coil MRI were 0.80, 0.64, respectively. Mean size of detected lesions with nonendorectal coil MRI were larger than those detected by dual-coil MRI (22 mm versus 17.4 mm). Conclusion Dual-coil prostate MRI detected more cancer foci than nonendorectal coil MRI. While nonendorectal coil MRI is an attractive alternative, physicians performing prostate MRI should be aware of its limitations. Copyright © 2013 Wiley Periodicals, Inc.


Turkbey B.,U.S. National Institutes of Health | Mani H.,U.S. National Institutes of Health | Aras O.,U.S. National Institutes of Health | Ho J.,U.S. National Institutes of Health | And 16 more authors.
Radiology | Year: 2013

Purpose: To determine whether multiparametric magnetic resonance (MR) imaging can help identify patients with prostate cancer who would most appropriately be candidates for active surveillance (AS) according to current guidelines and to compare the results with those of conventional clinical assessment scoring systems, including the D'Amico, Epstein, and Cancer of the Prostate Risk Assessment (CAPRA) systems, on the basis of findings at prostatectomy. Materials and Methods: This institutional review board-approved HIPAA-compliant retrospectively designed study included 133 patients (mean age, 59.3 years) with a mean prostate-specific antigen level of 6.73 ng/mL (median, 4.39 ng/mL) who underwent multiparametric MR imaging at 3.0 T before radical prostatectomy. Informed consent was obtained from all patients. Patients were then retrospectively classified as to whether they would have met AS eligibility criteria or were better served by surgery. AS eligibility criteria for prostatectomy specimens were a dominant tumor smaller than 0.5 mL without Gleason 4 or 5 patterns or extracapsular or seminal vesicle invasion. Conventional clinical assessment scores (the D'Amico, Epstein, and CAPRA scoring systems) were compared with multiparametric MR imaging findings for predicting AS candidates. The level of significance of difference between scoring systems was determined by using the x2 test for categoric variables with the level of significance set at P , .05. Results: Among 133 patients, 14 were eligible for AS on the basis of prostatectomy results. The sensitivity, positive predictive value (PPV), and overall accuracy, respectively, were 93%, 25%, and 70% for the D'Amico system, 64%, 45%, and 88% for the Epstein criteria, and 93%, 20%, and 59% for the CAPRA scoring system for predicting AS candidates (P , .005 for all, x2 test), while multiparametric MR imaging had a sensitivity of 93%, a PPV of 57%, and an overall accuracy of 92% (P , .005). Conclusion: Multiparametric MR imaging provides useful additional information to existing clinicopathologic scoring systems of prostate cancer and improves the assignment of treatment (eg, AS or active treatment). © RSNA, 2013.


Duryea J.,Harvard University | Neumann G.,Harvard University | Niu J.,Boston University | Totterman S.,United Virtual | And 6 more authors.
Arthritis Care and Research | Year: 2010

Objective. Magnetic resonance imaging (MRI) and radiography are established imaging modalities for the assessment of knee osteoarthritis (OA). The objective of our study was to compare the responsiveness of radiographic joint space width (JSW) with MRI-derived measures of cartilage morphometry for OA progression in participants from the Osteoarthritis Initiative (OAI). Methods. This study examined the baseline and 12-month visits of a subset of 150 subjects from the OAI. Measurement of radiographic JSW was facilitated by the use of automated software that delineated the femoral and tibial margins of the joint. Measures of medial compartment minimum JSW and JSW at fixed locations were compared with cartilage morphometry measures derived from MRI. The results were stratified by Kellgren/Lawrence (K/L) scale grade and by tibiofemoral anatomic axis angle. In order to examine the relative responsiveness of various techniques, we calculated the standardized response mean (SRM) between the 2 visits. Results. The SRM for radiographic JSW measured at the optimal location was -0.32 compared with -0.39 for the most responsive MRI measure. For the subgroup with a K/L scale grade of 2 or 3, the most responsive SRM values were -0.34 for radiographic JSW and -0.42 for MRI. Conclusion. Our study demonstrates that new measures using a software analysis of digital knee radiographic images are comparable with MRI in detecting OA progression, and potentially superior when considering the cost-effectiveness of the 2 imaging modalities. © 2010, American College of Rheumatology.


Ng C.S.,University of Texas M. D. Anderson Cancer Center | Raunig D.L.,Pfizer | Jackson E.F.,University of Texas M. D. Anderson Cancer Center | Ashton E.A.,VirtualScopics | And 4 more authors.
American Journal of Roentgenology | Year: 2010

OBJECTIVE. Dynamic contrast-enhanced MRI (DCE-MRI) is a potentially useful noninvasive technique for assessing tissue perfusion, particularly in the context of solid tumors and targeted antiangiogenic and antivascular therapies. Our aim was to determine the reproducibility of perfusion parameters derived at DCE-MRI of tumors of the lung and liver, the most common sites of metastasis. SUBJECTS AND METHODS. Patients with lung and liver tumors underwent two sequential DCE-MRI examinations 2-7 days apart without any intervening therapy. The volume transfer constant between blood plasma and the extravascular extracellular space (Ktrans) and blood-normalized initial area under the signal intensity-time curve (initial AUCBN) were computed with a two-compartment pharmacokinetic model. Differences in parameters were assessed with within-patient coefficients of variation. RESULTS. Twenty-three patients had evaluable tumors (12 lung, 11 liver). The withinpatient coefficients of variation for Ktrans and initial AUCBN for liver lesions were 8.9% and 9.9% and for lung lesions were 17.9% and 18.2%. Sample sizes for reductions in these parameters from 10% to 50% were estimated to range from two to 102 subjects. Estimates of con-fidence that changes observed in a given patient were due to intervening therapy rather than variability of the technique were calculated to range from 71% to 87% if a 20% reduction in a parameter was observed. CONCLUSION. The rate of reproducibility of DCE-MRI parameters is in the range of 10%-20% and is influenced by lesion location, parameters being significantly more reproducible in the liver than in the lung. These findings provide the foundation for interpretation of results and design of clinical trials in which DCE-MRI studies are used to assess objective responses. © American Roentgen Ray Society.


Ashton E.,VirtualScopics
Journal of Magnetic Resonance Imaging | Year: 2010

MRI has a wide variety of applications in the clinical trials process. MR has shown particular utility in the early phases of clinical development, when trial sponsors are interested in demonstrating proof of concept and must make decisions about allocation of resources to a particular compound based on the results from a small number of experimental subjects. This utility is largely due to the many different imaging endpoints that can be measured using MR, ranging from structural (tumor burden, hippocampal volume) to functional (blood flow, vascular permeability) to molecular (hepatic fat fraction, glycosaminoglycan content). The unique flexibility of these systems has proven to be both a blessing and a curse to those attempting to deploy MR in multi-center clinical trials, however, as differences among scanner manufacturers and models in pulse sequence implementation, hardware capabilities, and even terminology make it increasingly difficult to ensure that results obtained at one center are comparable to those at another. These problems are compounded by the differences between the procedures used in clinical trials and those used in routine clinical practice, which make trial-specific training for site technologists and radiologists a necessity in many cases. This article will briefly review the benefits of including quantitative MR imaging in clinical trials, then explore in detail the challenges presented by the need to develop and deploy a detailed MR protocol that is both effective and implementable across many different MR systems and software versions. © 2010 Wiley-Liss, Inc.


Ashton E.,VirtualScopics | Riek J.,VirtualScopics
Journal of Magnetic Resonance Imaging | Year: 2013

MRI has had a place in the clinical trials process for more than 20 years. However, for much of that time MRI has been used primarily for subjective interpretation and relatively straightforward structural measurements. More advanced MR techniques have been considered too difficult to implement consistently across multiple sites in a single trial - this despite the fact that these techniques often provide the best window into the direct effects of targeted therapeutics. As an example, numerous compounds are currently under development whose principle effect is to temporarily or permanently alter tumor microvasculature. Changes induced by these compounds typically manifest as reductions in blood flow and vascular permeability within tumors. These changes can be measured directly using dynamic contrast-enhanced MRI. Early studies using this technique were limited to single centers, limiting both the overall size of the studies and the rate at which they were able to accrue patients. Recent efforts, however, have demonstrated that with sufficient attention to protocol design, imaging site selection and training, and analysis standardization, it is possible to obtain consistent and high quality results using even relatively complex acquisition protocols. This article will briefly review both the benefits and the drawbacks of including advanced MR techniques in clinical trial protocols. It will then review in detail the challenges presented by the need to deploy these techniques both to large research institutions and to community imaging centers which may have little or no familiarity with them at the outset of the trial. © 2012 Wiley Periodicals, Inc.


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