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Protocol Number: 08-C-0200 
Abstract: -FLT PET/CT has been shown to correlate with the rate of cellular/tumor proliferation. -The Imaging Subcommittee of the International Harmonization Project in Lymphoma recommends performing FDG PET at least 3 weeks, and preferably 6-8 weeks after chemotherapy or chemoimmunotherapy therapy and 8- 12 weeks after radiation or chemoradiation therapy due to high FDG accumulation in inflammatory tissues. -FLT uptake in inflammatory lesions is less prominent than FDG and it is likely that FLT PET/CT can better differentiate inflammation from tumor. -FLT PET/CT imaging is expected to better differentiate between treatment induced inflammation and malignancy and should enable early prediction of therapeutic response. -FLT PET/CT imaging is expected to differentiate between residual inflammatory residual masses from residual malignancy and therefore guide appropriate treatment. Objectives: Primary Objectives: -To estimate the diagnostic accuracy of FLT PET/CT as an early indicator of complete response to therapy in B and T cell lymphoma. -To estimate the diagnostic accuracy of FLT PET/CT in the evaluation of residual masses after therapy. Secondary Objectives: -To compare the diagnostic accuracy of FLT PET/CT with that of FDG PET/CT predicting tumor response to therapy. -To evaluate whether FLT tumor uptake either prior to therapy or following completion of therapy are independent predictors of complete response to therapy. -To evaluate whether FLT tumor uptake either prior to therapy or following completion of therapy are independent predictors of progression free survival. -To evaluate whether there is a significant difference in tumor, selected normal organs, and mediastinal blood pool FDG SUV at 1 and 2 hours post injection. -To evaluate whether there is a significant difference in tumor, selected normal organs ,and mediastinal blood pool FLT dynamic influx parameter (Ki),SUV at 1 hours and 2 hours post injection. -To estimate the diagnostic accuracy of percent change in SUV between pre-treatment and mid-treatment FLT PET/CT with regard to complete response to therapy. -To estimate the diagnostic accuracy of percent change in SUV between pre-treatment and mid-treatment FLT PET/CT with regard to complete response to therapy progression free survival. Eligibility: -Participant must be enrolled in a lymphoma therapy study at the NIH Clinical Center OR be enrolled in the CALGB 50330 study at another site. The NCI Laboratory of Pathology will confirm diagnosis for subjects enrolled at all CALGB study sites. -Subjects enrolling in the early response arm must undergo baseline FLT PET prior to receiving lymphoma therapy. -Subjects enrolling in the residual mass evaluation arm can be enrolled at the time the FDG avid residual mass is discovered (i.e. no pre-therapy FLT image is required). -Subjects can enroll in both arms of the study. -Participant must be 18 years or older. -ECOG Performance score of 0 or 1. -SGOT, SGPT less than 5 times ULN. -bilirubin less than or equal to 2 times ULN. Design: -Subjects enrolling/enrolled in any lymphoma therapy trial at the NIH Clinical Center are eligible to participate in this imaging study. -There are 2 arms in this study ---The first arm will assess of FLT as an early predictor of tumor response to therapy (treatment naive or recurrent disease). Subjects are imaged with FLT and FDG PET pre-therapy, following 2 cycles of therapy and post therapy. ---The second arm will assess lymphoma patients with FDG PET positive residual mass. Subjects are imaged with FLT PET prior to standard of care biopsy of residual mass. If initial FDG PET data is not available in DICOM format or is of suboptimal image quality, a repeat FDG PET/CT at NIH may be required. -We will accrue 70 participants (40 in the early response arm and 30 in the residual mass arm) to this study.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009