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Delpassand E.S.,Excel Diagnostics and Nuclear Oncology Center | Delpassand E.S.,Radiomedix, Inc. | Samarghandi A.,Excel Diagnostics and Nuclear Oncology Center | Zamanian S.,Radiomedix, Inc. | And 11 more authors.
Pancreas | Year: 2014

OBJECTIVE: Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium 177 ( 177Lu) DOTATATE in patients with progressive NETs. METHODS: Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10%) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10%). RESULTS: Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28% and 3%, respectively, and stable disease was seen in 41% of patients. A total of 28% had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after 177Lu- DOTATATE therapy. CONCLUSIONS: Treatment with multiple cycles of 177Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved. Copyright © 2014 Lippincott Williams & Wilkins.

Kalinyak J.E.,Naviscan | Berg W.A.,University of Pittsburgh | Schilling K.,Boca Raton Regional Hospital | Madsen K.S.,Certus International Inc. | And 3 more authors.
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2014

Purpose: To compare the performance characteristics of positron emission mammography (PEM) with those of whole-body PET (WBPET) and PET/CT in women with newly diagnosed breast cancer. Methods: A total of 178 women consented to PEM for presurgical planning in an IRB-approved protocol and also underwent either WBPET (n =69) or PET/CT (n=109) imaging, as per usual care at three centers. Tumor detection sensitivity, positive predictive values, and 18F-fluorodeoxyglucose (FDG) uptake were compared between the modalities. The effects of tumor size, type, and grade on detection were examined. The chi-squared or Fisher's exact tests were used to compare distributions between groups, and McNemar's test was used to compare distributions for paired data within subject groups, i.e. PEM versus WBPET or PEM versus PET/CT. Results: The mean age of the women was 59±12 years (median 60 years, range 26-89 years), with a mean invasive index tumor size of 1.6±0.8 cm (median 1.5 cm, range 0.5-4.0 cm). PEM detected more index tumors (61/66, 92 %) than WBPET (37/66, 56 %; p<0.001) or PET/CT (95/109, 87 % vs. 104/109, 95 % for PEM; p <0.029). Sensitivity for the detection of additional ipsilateral malignancies was also greater with PEM (7/15, 47 %) than with WBPET (1/15, 6.7 %; p = 0.014) or PET/CT (3/23, 13 % vs. 13/23, 57 % for PEM; p = 0.003). Index tumor detection decreased with decreasing invasive tumor size for both WBPET (p =0.002) and PET/CT (p <0.001); PEM was not significantly affected (p =0.20). FDG uptake, quantified in terms of maximum PEM uptake value, was lowest in ductal carcinoma in situ (median 1.5, range 0.7-3.0) and invasive lobular carcinoma (median 1.5, range 0.7-3.4), and highest in grade III invasive ductal carcinoma (median 3.1, range 1.4-12.9). Conclusion: PEM was more sensitive than either WBPET or PET/CT in showing index and additional ipsilateral breast tumors and remained highly sensitive for tumors smaller than 1 cm. © Springer-Verlag Berlin Heidelberg 2013.

Berg W.A.,Hopkins Inc. | Berg W.A.,University of Pittsburgh | Madsen K.S.,Certus International Inc. | Schilling K.,Boca Raton Regional Hospital | And 7 more authors.
American Journal of Roentgenology | Year: 2012

OBJECTIVE. The objective of our study was to compare the performance of positron emission mammography (PEM) with that of MRI in the evaluation of the contralateral breast of women with newly diagnosed cancer. SUBJECTS AND METHODS. Four hundred seventy-two women with newly diagnosed breast cancer offered breast-conserving surgery from September 2006 through November 2008 consented to participate in a multicenter protocol. Participants underwent contrastenhanced breast MRI and 18F-FDG PEM in randomized order, and the examinations were interpreted independently. The performance characteristics of the imaging modalities were compared using the McNemar test and generalized estimating equations. A retrospective blinded review of PEM images was performed by four experienced observers to understand the reasons for false-negatives. RESULTS. Three hundred sixty-seven women (median age, 58 years; age range, 26-93 years) eligible for analysis completed the appropriate follow-up for study inclusion. Fifteen women (4.1%) were found to have contralateral cancer (11 invasive [mean tumor size, 12 mm; median, 10 mm; range, 1-22 mm] and four ductal carcinoma in situ). Of the 15 cases, both PEM and MRI showed three (20%), only MRI showed 11 (73%), and one (6.7%) was found at prophylactic mastectomy. MRI sensitivity at 14 of 15 (93%; 95% CI, 66-94) was higher than PEM at three of 15 (20%; 95% CI, 5.3-46) (p < 0.001). On PEM, three additional cancers were seen prospectively but were considered probably benign and two other cancers were visible in retrospect at the site. Of 352 contralateral breasts without cancer, findings were negative or benign on PEM for 335 (95.2%; 95% CI, 92.2-97.0), which is more than MRI at 315 (89.5%; 95% CI, 85.7-92.4; p = 0.002). The positive predictive value (PPV) of PEM-prompted biopsies (3/14 [21%]) was not significantly different from the PPV of MRI (15/54 [28%], p = 0.58). On blinded retrospective PEM review of the 15 contralateral cancers, PEM findings for 11 (73%) were considered suspicious. CONCLUSION. Contralateral cancer was found in 15 of 367 women (4.1%), with MRI showing 14 (93%). Eleven contralateral cancers (73%) were visible on PEM, but only three (20%) were recognized prospectively as suspicious. Lesions that are visible on PEM should be viewed as suspicious unless known to be benign by prior breast imaging or biopsy. © American Roentgen Ray Society.

Berg W.A.,American Green | Berg W.A.,The American College | Madsen K.S.,Certus International Inc. | Schilling K.,Boca Raton Community Hospital | And 10 more authors.
Radiology | Year: 2010

Purpose: To determine the performance of positron emission mammography (PEM), as compared with magnetic resonance (MR) imaging, including the effect on surgical management, in ipsilateral breasts with cancer. Materials and Methods: Four hundred seventy-two women with newly diagnosed breast cancer who were offered breast-conserving surgery consented from September 2006 to November 2008 to participate in a multicenter institutional review board-approved, HIPAA-compliant protocol. Participants underwent contrast material-enhanced MR imaging and fluorine 18 fluorodeoxyglucose PEM in randomized order; resultant images were interpreted independently. Added biopsies and changes in surgical procedure for the ipsilateral breast were correlated with histopathologic findings. Performance characteristics were compared by using the McNemar test and generalized estimating equations. Results: Three hundred eighty-eight women (median age, 58 years; age range, 26-93 years; median estimated tumor size, 1.5 cm) completed the study. Additional cancers were found in 82 (21%) women (82 ipsilateral breasts; median tumor size, 0.7 cm). Twenty-eight (34%) of the 82 breasts were identified with both PEM and MR imaging; 21 (26%) breasts, with MR imaging only; 14 (17%) breasts, with PEM only; and seven (8.5%) breasts, with mammography and ultrasonography. Twelve (15%) cases of additional cancer were missed at all imaging examinations. Integration of PEM and MR imaging increased cancer detection-to 61 (74%) of 82 breasts versus 49 (60%) of 82 breasts identified with MR imaging alone (P <.001). Of 306 breasts without additional cancer, 279 (91.2%) were correctly assessed with PEM compared with 264 (86.3%) that were correctly assessed with MR imaging (P =.03). The positive predictive value of biopsy prompted by PEM findings (47 [66%] of 71 cases) was higher than that of biopsy prompted by MR findings (61 [53%] of 116 cases) (P =.016). Of 116 additional cancers, 61 (53%) were depicted by MR imaging and 47 (41%) were depicted by PEM (P =.043). Fifty-six (14%) of the 388 women required mastectomy: 40 (71%) of these women were identified with MR imaging, and 20 (36%) were identified with PEM (P <.001). Eleven (2.8%) women underwent unnecessary mastectomy, which was prompted by only MR findings in five women, by only PEM findings in one, and by PEM and MR findings in five. Thirty-three (8.5%) women required wider excision: 24 (73%) of these women were identified with MR imaging, and 22 (67%) were identified with PEM. Conclusion: PEM and MR imaging had comparable breast-level sensitivity, although MR imaging had greater lesion-level sensitivity and more accurately depicted the need for mastectomy. PEM had greater specificity at the breast and lesion levels. Eighty-nine (23%) participants required more extensive surgery: 61 (69%) of these women were identified with MR imaging, and 41 (46%) were identified with PEM (P =.003). Fourteen (3.6%) women had tumors seen only at PEM. © RSNA, 2010.

Narayanan D.,Naviscan | Narayanan D.,U.S. National Institutes of Health | Madsen K.S.,Certus International Inc. | Kalinyak J.E.,Naviscan | And 2 more authors.
American Journal of Roentgenology | Year: 2011

OBJECTIVE. In preparation for a multicenter trial of positron emission mammography (PEM) and MRI in women with newly diagnosed cancer, the two purposes of this study were to validate training of breast imagers in standardized interpretation of PEM and to validate performance of the same specialists interpreting MRI. MATERIALS AND METHODS. A 2-hour didactic module was developed to train Mammography Quality Standards Act - qualified radiologist observers to interpret PEM images, consisting of a sample feature analysis lexicon analogous to BI-RADS and 12 sample cases. Observers were then asked to review separate interpretive skills tasks for PEM (49 breasts, 20 [41%] of which were malignant) and MRI (32 breasts, 11 [34%] of which were malignant), describe findings, and give assessments analogous to BI-RADS (category 1, 2, 3, 4A, 4B, 4C, or 5). Demographic experience variables were collected for 36 observers from 15 sites. Performance against histopathologic truth was determined, and interobserver agreement for classifying features and final assessments was evaluated using kappa statistics. RESULTS. Across 36 observers, mean sensitivity, specificity, and area under the curve (AUC) for PEM were 96% (range, 75-100%), 84% (range, 66-97%), and 0.95 (range, 0.82-1.0), respectively. Mean sensitivity, specificity, and AUC for the MRI task were 82% (range, 45-100%), 67% (range, 38-91%), and 0.80 (range, 0.48-0.96), respectively. Interobserver agreement for PEM findings ranged from moderate to substantial, with kappa values of 0.57 for lesion type and 0.63 for final assessments. CONCLUSION. With minimal training, experienced breast imagers showed high performance in interpreting PEM images. Performance in MRI interpretation by the same observers validated expected clinical practice. © American Roentgen Ray Society.

Narayanan D.,Naviscan | Narayanan D.,U.S. National Institutes of Health | Madsen K.S.,Certus International Inc. | Kalinyak J.E.,Naviscan | And 2 more authors.
American Journal of Roentgenology | Year: 2011

OBJECTIVE. The purpose of our study was to define and illustrate standard terminology for describing findings on positron emission mammography (PEM) and provide associated rates of malignancy. SUBJECTS AND METHODS. Three hundred eighty-eight women with newly-diagnosed breast cancer anticipating breast-conserving surgery completed a multicenter trial comparing PEM to MRI in assessment of disease extent. Morphologic terminology to describe PEM findings was patterned on BI-RADS for MRI, and investigators were trained in the PEM lexicon. PEM imaging features of known malignancies and additional PEM lesions were recorded and correlated with outcome. The reference standard was biopsy or at least a 6-month follow-up. RESULTS. Of 166 additional lesions on PEM, 54 (33%) proved malignant, with median invasive tumor size 8 mm (range, 2-60 mm). Among 43 round or oval masses, 16 (37%) were malignant, compared with 16 of 21 (76%) of lobulated or irregular masses (p = 0.003). Among 14 findings of focal or regional nonmass uptake, two (14%) were malignant compared with four of 12 (33%) findings of linear - ductal or segmental uptake (p = 0.350). Malignancy rates for BI-RADStype final assessments were category 2, one of 31 (3.2%); 3, three of 32 (9.4%); 4a, four of 18 (22%); 4b, nine of 33 (27%); 4c, 15 of 24 (63%); and 5, 22 of 28 (79%). On the basis of modeling, irregular or lobulated morphology was the strongest predictor of malignancy, followed by lesion laterality (i.e., ipsilateral to known cancer) then increasing semiquantitative 18F-FDG uptake. CONCLUSION. Use of standardized terminology to report PEM findings will facilitate effective communication of results and consistent management. A probably benign category 3 assessment carried a substantial rate of malignancy for lesions seen on PEM, and biopsy may be more appropriate than follow-up. © American Roentgen Ray Society.

Berman K.H.,Monsanto Corporation | Harrigan G.G.,Monsanto Corporation | Riordan S.G.,Monsanto Corporation | Nemeth M.A.,Monsanto Corporation | And 5 more authors.
Journal of Agricultural and Food Chemistry | Year: 2010

Brazil has become one of the largest soybean producers. Two Monsanto Co. biotechnology-derived soybean products are designed to offer benefits in weed and pest management. These are second-generation glyphosate-tolerant soybean, MON 89788, and insect-protected soybean, MON 87701. The second-generation glyphosate-tolerant soybean product, MON 89788, contains the 5-enolpyruvylshikimate-3-phosphate synthase gene derived from Agrobacterium sp. strain CP4 (cp4 epsps). MON 87701 contains the cry1Ac gene and expression of the Cry1Ac protein providing protection from feeding damage caused by certain lepidopteran insect pests. The purpose of this assessment was to determine whether the compositions of seed and forage of MON 89788 and MON 87701 are comparable to those of conventional soybean grown in two geographically and climatically distinct regions in multiple replicated sites in Brazil during the 2007-2008 growing season. Overall, results demonstrated that the seed and forage of MON 89788 and MON 87701 are compositionally equivalent to those of conventional soybean. Strikingly, the results also showed that differences in mean component values of forage and seed from the two controls grown in the different geographical regions were generally greater than that observed in test and control comparisons. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) of compositional data generated on MON 89788, MON 87701, and their respective region-specific controls provide a graphical illustration of how natural variation contributes more than biotechnology-driven genetic modification to compositional variability in soybean. Levels of isoflavones and fatty acids were particularly variable. © 2010 American Chemical Society.

Walsh J.C.,Siemens AG | Lebedev A.,Siemens AG | Aten E.,Certus International Inc. | Madsen K.,Certus International Inc. | And 2 more authors.
Antioxidants and Redox Signaling | Year: 2014

Tumor hypoxia is a well-established biological phenomenon that affects the curability of solid tumors, regardless of treatment modality. Especially for head and neck cancer patients, tumor hypoxia is linked to poor patient outcomes. Given the biological problems associated with tumor hypoxia, the goal for clinicians has been to identify moderately to severely hypoxic tumors for differential treatment strategies. The "gold standard" for detecting and characterizing of tumor hypoxia are the invasive polarographic electrodes. Several less invasive hypoxia assessment techniques have also shown promise for hypoxia assessment. The widespread incorporation of hypoxia information in clinical tumor assessment is severely impeded by several factors, including regulatory hurdles and unclear correlation with potential treatment decisions. There is now an acute need for approved diagnostic technologies for determining the hypoxia status of cancer lesions, as it would enable clinical development of personalized, hypoxia-based therapies, which will ultimately improve outcomes. A number of different techniques for assessing tumor hypoxia have evolved to replace polarographic pO2measurements for assessing tumor hypoxia. Several of these modalities, either individually or in combination with other imaging techniques, provide functional and physiological information of tumor hypoxia that can significantly improve the course of treatment. The assessment of tumor hypoxia will be valuable to radiation oncologists, surgeons, and biotechnology and pharmaceutical companies who are engaged in developing hypoxia-based therapies or treatment strategies. Antioxid. Redox Signal. 21, 1516-1554. © Copyright 2014, Mary Ann Liebert, Inc. 2014.

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