The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9
one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg \& 20 mg of GP will be injected
Houston Methodist Hospital
Houston, Texas, United States
RECRUITINGTo determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
Time frame: from 99mTc-GP injection through 30 days
To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.
Time frame: from 99mTc-GP injection through 30 days
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