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NCT00633958 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Dana-Farber Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT00633958: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.

NCT00633958 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00633958, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

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.

Interventions

  • RADIATION PET Imaging
  • DRUG 18F-FLT

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2008-03
Est. Completion 2010-03
Phase Phase 1
Dana-Farber Cancer Institute

781 total trials

Why NCT00633958 stopped before completion

NCT00633958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which PET Imaging is the first listed.

NCT00633958 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00633958 about?

NCT00633958 is a clinical study titled "A Pilot Study of 18F-FLT in Pediatric Patients With Central Nervous System (CNS) Tumors". 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...

What is the current status of trial NCT00633958?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2008-03. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00633958?

The interventions under investigation include: PET Imaging (RADIATION), 18F-FLT (DRUG).

Who is sponsoring clinical trial NCT00633958?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00633958's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00633958, the US trial registry maintained by the National Library of Medicine. NCT00633958 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.