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Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children

Phase 2
21 Years
Open (Enrolling by invite only)
Brain Neoplasms

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

[18F] FLT uptake as a marker of cellular proliferation

Outcome Description:

[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.

Outcome Time Frame:

on average 1 week

Safety Issue:


Principal Investigator

Frederick D Grant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital, Boston, Harvard Medical School


United States: Food and Drug Administration

Study ID:

IND 104356



Start Date:

October 2010

Completion Date:

September 2016

Related Keywords:

  • Brain Neoplasms
  • Brain neoplasms
  • Children
  • Positron-Emission Tomography
  • 18F-FLT
  • Brain Neoplasms
  • Neoplasms



Children's Hospital, Boston Boston, Massachusetts  02115