Spencer Fontayne Corporation

Jersey City, NJ, United States

Spencer Fontayne Corporation

Jersey City, NJ, United States
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Plasma proadrenomedullin (ProADM) is a blood biomarker that may aid in multidimensional risk assessment of patients with chronic obstructive pulmonary disease (COPD). Co-secreted 1:1 with adrenomedullin (ADM), ProADM is a less biologically active, more chemically stable surrogate for this pluripotent regulatory peptide, which due to biological and ex vivo physical characteristics is difficult to reliably directly quantify. Upregulated by hypoxia, inflammatory cytokines, bacterial products, and shear stress and expressed widely in pulmonary cells and ubiquitously throughout the body, ADM exerts or mediates vasodilatory, natriuretic, diuretic, antioxidative, anti-inflammatory, antimicrobial, and metabolic effects. Observational data from four separate studies totaling 1366 patients suggest that as a single factor, ProADM is a significant independent, and accurate, long-term all-cause mortality predictor in COPD. This body of work also suggests that combined with different groups of demographic/clinical variables, ProADM provides significant incremental long-term mortality prediction power relative to the groups of variables alone. Additionally, the literature contains indications that ProADM may be a global cardiopulmonary stress marker, potentially supplying prognostic information when cardiopulmonary exercise testing results such as 6-min walk distance are unavailable due to time or other resource constraints or to a patient's advanced disease. Prospective, randomized, controlled interventional studies are needed to demonstrate whether ProADM use in risk-based guidance of site-of-care, monitoring, and treatment decisions improves clinical, quality-of-life, or pharmacoeconomic outcomes in patients with COPD. © 2015 by De Gruyter.


Christ-Crain M.,University of Basel | Falconnier C.,University of Basel | Marlowe R.J.,Spencer Fontayne Corporation | Zimmerli W.,University of Basel
International Journal of Cardiology | Year: 2014

Background/objectives We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure (CHF) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection. Methods We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial. The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines (controls). The primary endpoint was a 30-day adverse outcome (death, intensive care unit admission); the secondary endpoints included a 30-day antibiotic exposure. Results In the 110/233 analyzed patients (47.2%) with low initial procalcitonin (< 0.25 μg/L), suggesting the absence of systemic bacterial infection, those randomized to procalcitonin guidance (n = 50) had a significantly lower adverse outcome rate compared to controls (n = 60): 4% vs. 20% (absolute difference - 16.0%, 95% confidence interval (CI) - 28.4% to - 3.6%, P = 0.01), and significantly reduced antibiotic exposure [days] (mean 3.7 ± 4.0 vs. 6.5 ± 4.4, difference - 2.8 [95% CI, - 4.4 to - 1.2], P < 0.01). When initial procalcitonin was ≥ 0.25 μg/L, procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes (25.8% vs. 24.6%, difference [95% CI] 1.2% [- 14.5% to 16.9%, P = 0.88]). Conclusions CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment. These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection. © 2014 Elsevier Ireland Ltd. All rights reserved.


Schierz J.-H.,Jena University Hospital | Opfermann T.,Jena University Hospital | Steenbeck J.,Jena University Hospital | Lopatta E.,Jena University Hospital | And 4 more authors.
Journal of Nuclear Medicine | Year: 2013

In addition to angiographic data on vascularity and vascular access, demonstration of hepatocellular carcinoma (HCC) liver nodule hypervascularization is a prerequisite for certain intrahepatic antitumor therapies. Early dynamic (ED) 18F-FDG PET/CT could serve this purpose when the current standard method, contrast-enhanced (CE) CT, or other CE morphologic imaging modalities are unsuitable. A recent study showed ED 18FFDG PET/CT efficacy in this setting but applied a larger-than-standard 18F-FDG activity and an elaborate protocol likely to hinder routine use. We developed a simplified protocol using standard activities and easily generated visual and descriptive or quantitative endpoints. This pilot study assessed the ability of these endpoints to detect HCC hyperperfusion and, thereby, evaluated the suitability in of the protocol everyday practice. Methods: Twenty-seven patients with 34 HCCs (diameter ≥ 1.5 cm) with hypervascularization on 3-phase CE CT underwent liver ED 18F-FDG PET for 240 s, starting with 18F-FDG (250-MBq bolus injection). Four frames at 15-s intervals, followed by 3 frames at 60-s intervals were reconstructed. Endpoints included focal tracer accumulation in the first 4 frames (60 s), subsequent focal washout, and visual and quantitative differences between tumor and liver regions of interest in maximum and mean ED standardized uptake value (ED SUVmax and ED SUVmean, respectively) 240-s time-activity curves. Results: All 34 lesions were identified by early focal 18F-FDG accumulation and faster time-to-peak ED SUVmax or ED SUVmean than in nontumor tissue. Tumor peak ED SUVmax and ED SUVmean exceeded liver levels in 85% and 53%, respectively, of lesions. Nadir tumor signal showed no consistent pattern relative to nontumor signal. HCC had a significantly shorter time to peak and significantly faster rate to peak for both ED SUVmax and ED SUVmean curves and a significantly higher peak ED SUVmax but not peak ED SUVmean than the liver. Conclusion: This pilot study provided proof of principle that our simplified ED 18F-FDG PET/CT protocol includes endpoints that effectively detect HCC hypervascularization; this finding suggests that the protocol can be used routinely. Copyright © 2013 by the Society of Nuclear Medicine and Molecular Imaging, Inc.


Darr A.M.,Jena University Hospital | Opfermann T.,Jena University Hospital | Niksch T.,Jena University Hospital | Driesch D.,Biocontrol | And 2 more authors.
Clinical Nuclear Medicine | Year: 2013

Purpose of the Report: The standard thyroid functional imaging method, 99mTc-pertechnetate (99mTc-PT) planar scintigraphy, has technical drawbacks decreasing its sensitivity in detecting nodules or anatomical pathology. 124IPET, lacking these disadvantages and allowing simultaneous CT, may have greater sensitivity for these purposes. We performed a blinded pilot comparison of 124I-PET(/CT) versus 99mTc-PT planar scintigraphy or its cross-sectional enhancement, 99mTc-PT single-photon emission CT (SPECT), in characterizing the thyroid gland with benign disease. Patients and Methods: Twenty-one consecutive adults with goiter underwent low-activity (1 MBq/0.027 mCi) 124I-PET/low-dose (30 mAs) CT, 99mTc-PT planar scintigraphy, and 99mTc-PT-SPECT. Endpoints included the numbers of "hot spots" with/without central photopenia and "cold spots"detected, the proportion of these lesions with morphological correlates, the mean volume and diameter of visualized nodules, and the number of cases of lobus pyramidalis or retrosternal thyroid tissue identified. Results: 124I-PET detected significantly more "hot spots" with/without central photopenia (P < 0.001), significantly more nodules (P < 0.001), and more "cold spots" than did 99mTc-PT planar scintigraphy or 99mTc-PT-SPECT, including all lesions seen on the 99mTc-PT modalities. Ultrasonographic correlates were found for all nodules visualized on all 3 modalities and 92.5% of nodules seen only on 124I-PET. Nodules discernible only on 124I-PET had significantly smaller mean volume or diameter (P < 0.001) than did those visualized on 99mTc-PT planar scintigraphy or 99mTc-PT-SPECT. 124I-PET(/CT) identified significantly more patients with a lobus pyramidalis (P < 0.001) or retrosternal thyroid tissue (P G 0.05). Conclusions: 124I-PET(/CT) may provide superior imaging of benign thyroid disease compared to planar or cross-sectional 99mTc-PT scintigraphy. Copyright © 2013 by Lippincott Williams & Wilkins.


Frangos S.,Bank of Cyprus Oncology Center | Iakovou I.P.,Aristotle University of Thessaloniki | Marlowe R.J.,Spencer Fontayne Corporation | Eftychiou N.,Bank of Cyprus Oncology Center | And 5 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2015

Purpose: We determined the reasons for radioiodine thyroid remnant ablation, and the procedure’s necessity based on postsurgical remnant size, in patients with putatively “low–intermediate-risk” differentiated thyroid carcinoma (DTC). We identified key clinicopathological, treatment and remnant characteristics, and factors associated with remnant size in 336 patients with pT1/2, M0 DTC ablated during the period September 2010 to October 2013 at one Cypriot or one Greek referral centre. Methods: Clinicopathological/treatment characteristics were compiled from charts. Experienced nuclear medicine physicians rated the numbers/intensities of uptake foci in the thyroid bed on postablation planar scintigrams using scales of 0–4 points and 0–3 points, respectively. The product of these scores was taken as the “remnant score” that ranged from 0 (no remnant) to 12 (multiple remnants, intense uptake). Results: DTC was predominantly papillary. The median [25th–75th percentile] longest primary tumour diameter was 1.0 cm [0.7–1.5 cm]. Despite favourable histotypes and primary tumour classifications, patients often had preablation characteristics suggesting elevated or uncertain risk: 31.0 % of patients (104 of 336) had primary tumour multifocality, 22.0 % (74) had confirmed cervical lymph node metastases, 37.2 % (125) had unknown nodal status, and 38.1 % (128) had antithyroglobulin antibody seropositivity. The median [25th–75th percentile] remnant score was 4 [2–6]; 39.9 % of patients (134 of 336) had scores ≥6. For the entire cohort, T or N stages (r ≤ 0.174, P ≤ 0.05) correlated positively with the remnant score in a univariate Spearman analysis. The numbers of patients referred by the surgeon, cervical lymph nodes excised and metastatic nodes excised correlated negatively (r ≤ 0.243, P ≤ 0.038) with the remnant score, and the first two factors independently predicted the remnant score (P ≤ 0.037) in a multivariate analysis. Conclusion: Patients with putatively “low–intermediate-risk” DTC frequently had disease characteristics denoting high or uncertain risk, suggesting that “selective” radioiodine ablation in such patients may seldom be applicable outside international centres of excellence. Proxies for surgeon experience and surgical completeness correlated with remnant number/uptake intensity and may aid ablation-related decision-making. © 2015, Springer-Verlag Berlin Heidelberg.


PubMed | Spencer Fontayne Corporation, Aristotle University of Thessaloniki and Bank of Cyprus Oncology Center
Type: | Journal: European journal of nuclear medicine and molecular imaging | Year: 2016

Typically formulated by investigators from world centres of excellence, differentiated thyroid carcinoma (DTC) management guidelines may have more limited applicability in settings of less expert care and fewer resources. Arguably the worlds leading DTC guidelines are those of the American Thyroid Association, revised in 2009 (ATA 2009) and 2015 (ATA 2015). To further explore the issue of real-world applicability of DTC guidelines, we retrospectively compared indications for ablation using ATA 2015 versus ATA 2009 in a two-centre cohort of ablated T1-2, M0 DTC patients (N=336). Based on TNM status and histology, these patients were low-intermediate risk, but many ultimately had other characteristics suggesting elevated or uncertain risk.Working by consensus, two experienced nuclear medicine physicians considered patient and treatment characteristics to classify each case as having no indication, a possible indication, or a clear indication for ablation according to ATA 2009 or ATA 2015. The physicians also identified reasons for classification changes between ATA 2015 versus ATA 2009. Classification was unblinded, but the physicians had cared for only 138/336 patients, and the charts encompassed September 2010-October 2013, several years before the classification was performed.One hundred of 336 patients (29.8%) changed classification regarding indication for ablation using ATA 2015 versus ATA 2009. Most reclassified patients (70/100) moved from no indication or clear indication to possible indication. Reflecting this phenomenon, possible indication became the largest category according to the ATA 2015 classification (141/336, 42.0%, versus 96/336, 28.6%, according to ATA 2009). Many reclassifications were attributable to multiple clinicopathological characteristics, most commonly, stimulated thyroglobulin or anti-thyroglobulin antibody levels, multifocality, bilateral involvement, or capsular/nodal invasion.Regarding indications for ablation, ATA 2015 appears to better acknowledge grey areas, i.e., patients with ambiguous or unavailable data requiring individualised, nuanced decision-making, than does ATA 2009.


PubMed | Spencer Fontayne Corporation, Aristotle University of Thessaloniki and Bank of Cyprus Oncology Center
Type: Evaluation Studies | Journal: European journal of nuclear medicine and molecular imaging | Year: 2015

We determined the reasons for radioiodine thyroid remnant ablation, and the procedures necessity based on postsurgical remnant size, in patients with putatively low-intermediate-risk differentiated thyroid carcinoma (DTC). We identified key clinicopathological, treatment and remnant characteristics, and factors associated with remnant size in 336 patients with pT1/2, M0 DTC ablated during the period September 2010 to October 2013 at one Cypriot or one Greek referral centre.Clinicopathological/treatment characteristics were compiled from charts. Experienced nuclear medicine physicians rated the numbers/intensities of uptake foci in the thyroid bed on postablation planar scintigrams using scales of 0-4 points and 0-3 points, respectively. The product of these scores was taken as the remnant score that ranged from 0 (no remnant) to 12 (multiple remnants, intense uptake).DTC was predominantly papillary. The median [25th-75th percentile] longest primary tumour diameter was 1.0 cm [0.7-1.5 cm]. Despite favourable histotypes and primary tumour classifications, patients often had preablation characteristics suggesting elevated or uncertain risk: 31.0% of patients (104 of 336) had primary tumour multifocality, 22.0% (74) had confirmed cervical lymph node metastases, 37.2% (125) had unknown nodal status, and 38.1% (128) had antithyroglobulin antibody seropositivity. The median [25th-75th percentile] remnant score was 4 [2-6]; 39.9% of patients (134 of 336) had scores 6. For the entire cohort, T or N stages (r0.174, P0.05) correlated positively with the remnant score in a univariate Spearman analysis. The numbers of patients referred by the surgeon, cervical lymph nodes excised and metastatic nodes excised correlated negatively (r0.243, P0.038) with the remnant score, and the first two factors independently predicted the remnant score (P0.037) in a multivariate analysis.Patients with putatively low-intermediate-risk DTC frequently had disease characteristics denoting high or uncertain risk, suggesting that selective radioiodine ablation in such patients may seldom be applicable outside international centres of excellence. Proxies for surgeon experience and surgical completeness correlated with remnant number/uptake intensity and may aid ablation-related decision-making.


Freudenberg L.S.,University of Duisburg - Essen | Jentzen W.,University of Duisburg - Essen | Petrich T.,Leibniz University of Hanover | Fromke C.,Leibniz University of Hanover | And 5 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2010

Purpose: Renal radioiodine excretion is ~50% faster during euthyroidism versus hypothyroidism. We therefore sought to assess lesion dose/GBq of administered 131I activity (LDpA) in iodine-avid metastases (IAM) of differentiated thyroid carcinoma (DTC) in athyreotic patients after recombinant human thyroid-stimulating hormone (rhTSH) versus after thyroid hormone withdrawal (THW). Methods: We retrospectively compared mean LDpA between groups of consecutive patients (N=63) receiving 124I positron emission tomography/computed tomography (124I PET/CT) aided by rhTSH (n=27) or THW (n=36); we prospectively compared LDpA after these stimulation methods within another individual. Data derived from serial PET scans and one CT scan performed 2-96 h post-124I ingestion. A mixed model analysis of covariance (ANCOVA) calculated the treatment groups' mean LDpAs adjusting for statistically significant baseline intergroup differences: non-IAM were more prevalent, median IAM count/patient lower in cervical lymph nodes and higher in distant sites, median stimulated thyroglobulin higher, mean cumulative radioiodine activity greater and prior diagnostic scintigraphy more frequent in the rhTSH patients. Results: Mean LDpAs were: rhTSH group (n=71 IAM), 30.6 Gy/GBq; THW group (n=66 IAM), 51.8 Gy/GBq. The difference in group means (rhTSH less THW), -21.2 Gy/GBq, was statistically non-significant (p=0.1667). However, the 95% confidence interval of that difference (-51.4 to +9 Gy/GBq) suggested a trend favouring THW. The within-patient comparison found 2.9- to 10-fold higher LDpAs under THW. Conclusion: We found some suggestions, but no statistically significant evidence, that rhTSH administration results in a lower radiation dose to DTC metastases than does THW. A large, well-controlled, prospective within-patient study should resolve this issue. © 2010 Springer-Verlag.


Verburg F.A.,University of Würzburg | Verburg F.A.,University Utrecht | Stokkel M.P.M.,Leiden University | Duren C.,University of Würzburg | And 7 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2010

Purpose: To compare disease-specific survival and recurrence-free survival (RFS) after successful 131I ablation in patients with differentiated thyroid carcinoma (DTC) between those defined before ablation as low-risk and those defined as high-risk according to the European Thyroid Association 2006 consensus statement. Methods: Retrospective data from three university hospitals were pooled. Of 2009 consecutive patients receiving ablation, 509 were identified as successfully ablated based on both undetectable stimulated serum thyroglobulin in the absence of antithyroglobulin antibodies and a negative diagnostic whole-body scan in a follow-up examination conducted 8.1±4.6 months after ablation. Of these 509 patients, 169 were defined as high-risk. Results: After a mean follow-up of 81±64 months (range 4-306 months), only three patients had died of DTC, rendering assessment of disease-specific survival differences impossible. Of the 509 patients, 12 (2.4%) developed a recurrence a mean 35 months (range 12-59 months) after ablation. RFS for the duration of follow-up was 96.6% according to the Kaplan-Meier method. RFS did not differ between high-risk and low-risk patients (p=0.68). RFS differed slightly but significantly between those with papillary and those with follicular thyroid carcinoma (p=0.03) and between those aged 45 years those aged >45 years at diagnosis (p=0.018). Conclusion: After (near) total thyroidectomy and successful 131I ablation, RFS does not differ between patients classified as high-risk and those classified as low-risk based on TNM stage at diagnosis. Consequently, the follow-up protocol should be determined on the basis of the result of initial treatment rather than on the initial tumour classification. © 2009 Springer-Verlag.


Clerc J.,University of Paris Pantheon Sorbonne | Bienvenu-Perrard M.,University of Paris Pantheon Sorbonne | Pichard De Malleray C.,University of Paris Pantheon Sorbonne | Dagousset F.,University of Paris Pantheon Sorbonne | And 6 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: In low-risk differentiated thyroid cancer (DTC), postoperative 131I remnant ablation should employ a minimum effective activity; reports increasingly suggest efficacy of low activities, e.g. 1110 MBq/30 mCi. Objectives, Design, Patients, and Interventions:Weretrospectively studied the ablation capability and diagnostic utility of the Minidose protocol, two 740-MBq/20 mCi outpatient administrations, 6-18 months apart, plus related diagnostic procedures, in 160 consecutive (near-) totally thyroidectomized low-risk DTC (pT1/N0-Nx) patients. Successful ablation comprised negative 740-MBq whole-body scintigraphy with cervical uptake below 0.1%, negative stimulated thyroglobulin (STg) (<1 ng/ml, negative thyroglobulin antibodies), and negative Doppler ultrasonography (performed around Minidose 2). Setting: The study took place at a referral center. Results: Minidose imaging found unsuspected nodal or distant metastases in nine of 160 patients (5.6%). Ablation success rates after one (two) 740-MBq activity (activites) were 75.9% (90.2%) in 145 (132) evaluable imaging-negative patients. Compared with thyroid hormone withdrawal, recombinant human TSH stimulation was associated with higher urinary iodine excretion/creatinine, lower cervical uptake, and more frequent ablation success after the first 740 MBq; success rates no longer differed significantly after both administrations. Patients with STg below 10 ng/ml at Minidose 1 were oftener ablated at Minidose 2 (odds ratio = 13.9, 95% confidence interval =2.5-76.4, P < 0.003), attaining 92.0% final ablation success after recombinant human TSH preparation, suggesting that one 740-MBq activity should suffice in this subgroup. All 81 evaluable patients with prolonged follow-up (mean 41.8 ± 21.9 months after Minidose 1) had no evidence of disease at the last visit. Conclusions: The Minidose outpatient ablation protocol is effective and diagnostically useful in low-risk DTC. Copyright © 2012 by The Endocrine Society.

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