Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
Although pediatric central nervous system tumors are rare, they are a significant
contributor to morbidity and mortality in children. Tumor staging, detecting recurrent
tumor, and assessing the response to therapy are critical in the treatment of brain tumors,
but current imaging methods have major limitations in providing such information. The
objective of this study is to validate 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) as a
measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging
agent in children with central nervous system tumors. The proposed studies will evaluate
18F-FLT PET in three groups:
1. Children with a new diagnosis of central nervous system tumor.
2. Children in whom conventional imaging has raised concern for possible recurrence of a
central nervous system tumor.
3. Children receiving post-operative chemotherapy for a central nervous system tumor.
In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient
outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for
accurate identification of tumor recurrence, and for early assessment of the response to
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
[18F] FLT uptake as a marker of cellular proliferation
[18F] FLT uptake, as determined by pre-operative FLT-PET imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.
on average 1 week
Frederick D Grant, MD
Children's Hospital, Boston, Harvard Medical School
United States: Food and Drug Administration
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