A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
Cohorts of 3 will be treated each at different dose levels and images will be taken at 4
time points. For dosimetry estimates, there will be a 20-24 hr time point
post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and
dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will
eliminate that 4th scan for all other patients. Urine and blood samples will be collected at
5 time points, and an additional blood and urine sample will be collected for dosimetry
analysis at 30~60 min.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
from 99mTc-GP injection through 30 days
Isis Gayed, M.D.
The University of Texas Health Science Center, Houston
United States: Food and Drug Administration
|Memorial Hermann Hospital||Houston, Texas 77030|