Status:
UNKNOWN
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Lead Sponsor:
SeeCure LLC
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01159405
Start Date
June 1 2010
End Date
April 1 2015
Last Update
July 30 2014
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030