NCT00553748

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a ten subject, phase 1 study. The purpose of the study is to demonstrate drug safety in a group with high grade brain tumors and to evaluate cell proliferation with F-18 FLT. FLT is known to clear out of normal brain and detect brain tumor. This population represents a potential clinical population that may benefit from this PET imaging tracer. This information will help improve the design and conduct of future F-18 FLT clinical trials.

Conditions

• Brain Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-11-06
• Last updated: 2008-07-03

Locations

1 site across 1 country: United States