Phase 2
Completed N=50
FLT-PET Imaging of Brain Tumors in Children
Source: ClinicalTrials.gov NCT01244737 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Jul 2024
Primary outcomePrimary: [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation — 1.57; 3.00 SUV max — p=< 0.001
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation |
1.57; 3.00 | < 0.001 sig |
| PRIMARY MIB Positive (Percent) |
17.3; 32.8 | — |
| SECONDARY Biodistribution of [18F]FLT |
— | — |
| SECONDARY Preliminary Evaluation of Clinical Utility of [18F] FLT PET |
0.85; 0.47 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- age 21 years or less
- capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
- Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
- Patients receiving steroids and/or anti-seizure medications are eligible
Exclusion Criteria
- clinically active infection
- pregnancy or breast-feeding
- serious intercurrent medical illness
- require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging
Data sourced from ClinicalTrials.gov (NCT01244737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.