A Phase I, Open Label, Single Center Safety Study of [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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Safety will be demonstrated through analysis of adverse events in subjects enrolled in the trial who received study drug
Charles M Intenzo, MD
Thomas Jefferson University Hospital, 132 S 10th St Phila, PA 19107
United States: Food and Drug Administration
|Thomas Jefferson University Hospital||Philadelphia, Pennsylvania 19131|