A Pilot Study of 18F-FLT in Pediatric Patients With Central Nervous System (CNS) Tumors

Stopped early · Phase 1

Conditions studied: Tumors of the Central Nervous System

In brief

In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade lesions due to their increased glucose metabolism, the high tracer uptake of the normal adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a new imaging agent that has two significant advantages in the imaging of CNS tumors. First, this agent detects cellular proliferation directly, and second, the normal brain does not take up the agent, making a positive area(s) easy to identify. Before embarking on a large pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients, the investigators are proposing a limited patient pilot study to evaluate the biodistribution, dosimetry and specificity of this compound when compared to immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing surgical resection.

Key facts

Study ID

NCT00633958

Run by

Dana-Farber Cancer Institute

People needed

2

Starts

2008-03-01

Expected to finish

2010-03-01

Last updated by the study team

2021-10-20

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients with newly diagnosed central nervous system tumors undergoing planned surgical resection within 21 days.
• Patients should be < 21 years of age at the time of diagnosis.
• Patients should be capable of achieving imaging without the need for sedation or anesthesia.
• Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted.
• Patients must not be pregnant or nursing.
• Signed Informed Consent.
• Patients receiving steroids and/or anti-seizure medications are eligible for this study.

You may not qualify if…

• Prior radiation therapy and/or chemotherapy are not permitted.
• Active infection
• Pregnancy or breast feeding
• Serious concurrent medical illness

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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