Trial Information

A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma

Background:

- 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.

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.

Eligibility:

- Participant must be enrolled in a lymphoma therapy study at the NIH Clinical Center OR
be enrolled in the CALGB 50303 study at another site OR undergoing a new course of
treatment of lymphoma at another facility. The NCI Laboratory of Pathology will confirm
diagnosis for subjects enrolled at all CALGB study sites.

- Participants must have a clinical course consistent with lymphoma and have available
documentation of lymphoma from either the NCI or from an outside pathology laboratory.

- Subjects enrolling in the early response arm must undergo baseline FLT PET prior to
receiving a new course of 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:

- 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 the study site may be required.

- We will accrue 70 participants (40 in the early response arm and 30 in the residual
mass arm) to this study.