Detailed Description | |
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Modalities | PT, CT, MR, CR, DX, SC
| Number of Patients | 193 | Number of Studies | 828 | Number of Series | 2,981 | Number of Images | 436,165 | Image Size (GB) | 127.8 |
Study Accrual: Accrual began in June 2005 and ended in May 2009. Thirty-seven institutions accrued 250 patients to the study. Sixteen patients were ineligible, and eight patients did not have evaluable pretreatment PET, leaving 226 patients. Of these 226 patients, 173 had evaluable post- treatment PET, representing the analysis cohort for the primary end point. Imaging Protocol: Conventional modern equipment/techniques for FDG-PET (with or without PET/CT) were used in this study. Patients had to fast for 4 hours and have a blood glucose level less than 200 mg/dL before FDG injection. The FDG dose was not mandated; the recommended dose was 0.14 to 0.21 mCi/kg (approximately 10 to 20 mCi). Emission scanning began 50 to 70 minutes after FDG injection and included the body from upper/mid neck to proximal femurs. Acquisition times for emission and transmission scans were in accordance with the manufacturer’s recommendations. Image Analysis: PET scans were interpreted qualitatively and quantitatively by nuclear medicine physicians/radiologists at each institution, using standardized reporting forms to record the FDG uptake in the primary tumor, regional lymph nodes, and common sites of distant metastasis (ie, bones, adrenals, liver, contralateral lung). These local reviewers were provided with educational materials on image interpretation, specifically describing how to measure peak SUV (SUVpeak). However, formal demonstration of expertise was not mandated. SUVs for regions of interest (ROIs) were determined using two different metrics, maximum SUV (SUVmax) and SUVpeak. SUVmax represented the highest single-voxel SUV within the ROI. SUVpeak represented the mean SUV within a small circular ROI (0.75 to 1.5 cm in diameter) that encompasses the SUVmax voxel. (Thus, SUVpeak will always be lower than SUVmax.). In addition to the institutional interpretations, pre- and post-treatment PET scans were centrally reviewed at ACRIN by an expert nuclear medicine physician with extensive experience in FDG-PET. A single dedicated workstation was used for this purpose, and SUVpeak was measured with an automated program in a circular ROI 1.5 cm in diameter. The central reader was blinded to clinical data and the institutional SUV measurements. Outcomes: Patients were observed for a minimum of 2 years (or until death) after completion of treatment in accordance with standard clinical practice. Non-protocol PET imaging was allowed but not mandated. Schema
Much more information about this data set (ACRIN 6668 / RTOG 0235) can be found https://www.acrin.org/6668_protocol.aspx |