Phase I, Open Label, Single Center Safety Study of [F-18]FLT
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Phase I, Open Label, Single Center Safety Study of [F-18]FLT|
- Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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.
Other Name: 18-F FLT; [F-18]FLT
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553748
|United States, Pennsylvania|
|Thomas Jefferson University Hospital|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Charles M Intenzo, MD||Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107|