Clinical trial NCT01244737: FLT-PET Imaging of Brain Tumors in Children
Official title: Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: Brain neoplasms
Children
Positron-Emission Tomography
18F-FLT
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2010-11-19
Enrollment: 50
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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)

Detailed description: 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.

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

Primary outcomes:
measure: [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
timeFrame: on average 1 week
measure: MIB Positive (Percent)
timeFrame: 30 days
Secondary outcomes:
measure: Biodistribution of [18F]FLT
timeFrame: 6 hours
measure: Preliminary Evaluation of Clinical Utility of [18F] FLT PET
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital, Boston
state: Massachusetts
Study officials:
affiliation: Children's Hospital, Boston, Harvard Medical School
name: Frederick D Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: