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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
Patients with newly diagnosed stage I-IV breast cancer (tumor size
Patients must have histological diagnosis of invasive breast cancer.
Extent of disease will be determined by physical examination and conventional radiological studies.
Must be age 18 or older.
ECOG performance status 0-2.
Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.
Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is acceptable).
Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.
Adequate kidney function (creatinine < 1.5 mg/dL).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Central trial contact
Ning Tsao, PhD; Chung Wei Huang, Master
Data sourced from clinicaltrials.gov
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