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Pivot X.,University Hospital Jean Minjoz | Lortholary A.,Catherine Of Sienne Center | Abadie-Lacourtoisie S.,Paul Papin Center | Mefti-Lacheraf F.,Rene Huguenin Center | And 3 more authors.
Breast | Year: 2011

Purpose: The aim of this study was to demonstrate the renal safety equivalence of ibandronate 6 mg infused over 15 min versus 60 min, in patients with bone metastases of breast cancer. Patients and methods: Patients were females having breast cancer with at least one bone metastasis. Exclusion criteria were renal failure (creatinine clearance < 30 mL/min), tooth/jaw disorder or uncontrolled severe disease. Eligible patients were randomly assigned to receive nine ibandronate 6 mg i.v. infusions over either 15 min or 60 min. The primary outcome was the 95% confidence interval (CI) of the difference in creatinine clearance between groups, 28 days after the last infusion. The equivalence margin was ±8 mL/min. Results: Overall 334 patients were randomized (165-15 min infusions vs. 169 to 60 min infusions, 325 (159 vs. 166) were analyzed by intent-to-treat, and 312 (151 vs. 161) were analyzed per protocol. Per protocol, the 15 min-60 min difference in creatinine clearance [95% CI] was -3.00 [-8.18, 2.18]. By intent-to-treat, this difference was-2.91 [-7.99, 2.16]. Death and serious adverse event rates did not differ between groups. Three serious adverse events were considered related to ibandronate: an osteonecrosis of the jaw (15-min group), a pain in jaw and an enamel cracking (60-min group). Two renal failures, reported in the 60 min group, were not considered related to ibandronate. None occurred in the 15 min group. Conclusion: Ibandronate may be infused over 15 min without clinically significant consequence on renal safety. © 2011 Elsevier Ltd. Source

Thureau S.,University of Rouen | Chaumet-Riffaud P.,University Paris - Sud | Modzelewski R.,University of Rouen | Fernandez P.,Bordeaux University Hospital Center | And 20 more authors.
Journal of Nuclear Medicine | Year: 2013

As the preparation phase of a multicenter clinical trial using 18Ffluoro- 2-deoxy-D-glucose (18F-FDG), 18F-fluoromisonidazole (18FFMISO), and 3′-deoxy-3′-18F-fluorothymidine (18F-FLT) in non-small cell lung cancer (NSCLC) patients, we investigated whether 18 nuclear medicine centers would score tracer uptake intensity similarly and define hypoxic and proliferative volumes for 1 patient and we compared different segmentation methods. Methods: Ten 18F-FDG, ten 18F-FMISO, and ten 18F-FLT PET/CT examinations were performed before and during curative-intent radiotherapy in 5 patients with NSCLC. The gold standards for uptake intensity and volume delineation were defined by experts. The between-center agreement (18 nuclear medicine departments connected with a dedicated network, SFMN-net [French Society of Nuclear Medicine]) in the scoring of uptake intensity (5-level scale, then divided into 2 levels: 0, normal; 1, abnormal) was quantified by κ-coefficients (κ). The volumes defined by different physicians were compared by overlap and k. The uptake areas were delineated with 22 different methods of segmentation, based on fixed or adaptive thresholds of standardized uptake value (SUV). Results: For uptake intensity, the k values between centers were, respectively, 0.59 for 18F-FDG, 0.43 for 18F-FMISO, and 0.44 for 18F-FLT using the 5-level scale; the values were 0.81 for 18F-FDG and 0.77 for both 18F-FMISO and 18F-FLT using the 2-level scale. The mean overlap and mean κ between observers were 0.13 and 0.19, respectively, for 18F-FMISO and 0.2 and 0.3, respectively, for 18FFLT. The segmentation methods yielded significantly different volumes for 18F-FMISO and 18F-FLT (P < 0.001). In comparison with physicians, the best method found was 1.5×maximum SUV (SUVmax) of the aorta for 18F-FMISO and 1.3×SUVmax of the muscle for 18F-FLT. The methods using the SUV of 1.4 and the method using 1.5×the SUVmax of the aorta could be used for 18F-FMISO and 18F-FLT. Moreover, for 18F-FLT, 2 other methods (adaptive threshold based on 1.5 or 1.6×muscle SUVmax) could be used. Conclusion: The reproducibility of the visual analyses of 18F-FMISO and 18F-FLT PET/CT images was demonstrated using a 2-level scale across 18 centers, but the interobserver agreement was low for the 18F-FMISO and 18FFLT volume measurements. Our data support the use of a fixed threshold (1.4) or an adaptive threshold using the aorta background to delineate the volume of increased 18F-FMISO or 18F-FLT uptake. With respect to the low tumor-on-background ratio of these tracers, we suggest the use of a fixed threshold (1.4). COPYRIGHT © 2013 by the Society of Nuclear Medicine and Molecular Imaging, Inc. Source

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