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The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer

2014-08-27 03:12:18 | BioPortfolio

Summary

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.

Description

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 Design

Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Breast Cancer

Intervention

Radiolabeled (99mTc) GP (Glycopeptide)

Location

Memorial Hermann Hospital
Houston
Texas
United States
77030

Status

Recruiting

Source

SeeCure LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:18-0400

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