Breast Cancer Clinical Trial
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
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.
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.
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed stage I-IV breast cancer (tumor size
2cm in imaging examinations) who are scheduled to start systemic therapy.
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:
Patients who received previous chemotherapy for the newly diagnosed breast cancer.
No evidence of primary breast lesion (e.g. T0, Tx).
Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.
Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.
Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
Sub-Investigator
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.