Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-\[F-18\] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)
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 chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
50
\[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Children's Hospital, Boston
Boston, Massachusetts, United States
[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
\[18F\] FLT uptake, as determined by pre-operative positron emission tomography (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.
Time frame: on average 1 week
MIB Positive (Percent)
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining
Time frame: 30 days
Biodistribution of [18F]FLT
The distribution, localization, and kinetics of localization of \[18F\] FLT will be assessed by FLT-PET in 12 subjects.
Time frame: 6 hours
Preliminary Evaluation of Clinical Utility of [18F] FLT PET
In individuals with a diagnosed primary brain tumor in whom therapy will include chemotherapy,.\[18F\] FLT uptake, as determined by positron emission tomography (PET) imaging, will assessed before and after two cycles of chemotherapy. Response will be determined by comparing the FL uptake before and after therapy.
Time frame: 3 months
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