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Phase I, Open Label, Single Center Safety Study of [F-18]FLT

NCT00553748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2008-07-03

No results posted yet for this study

Summary

This is a ten subject, phase 1 study. The purpose of the Phase 1 study is to demonstrate drug safety in a target group of subjects with high grade brain cancer. This population represents a potential clinical population that may benefit from this PET imaging tracer. The study will also begin collection of baseline imaging data and allow us to gain information to improve design and conduct of future trials.

Conditions

Interventions

DRUG

F-18 FLT

One - 10 mci dose of F-18 FLT is administered IV over about 5 seconds prior to PET imaging. Each imaging dose contains no more than 6.1 micrograms of FLT.

Sponsors & Collaborators

  • Siemens Molecular Imaging

    lead INDUSTRY

Principal Investigators

  • Charles M Intenzo, MD · Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553748 on ClinicalTrials.gov