The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Status unconfirmed · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01159405
- Run by
- SeeCure LLC
- People needed
- 9
- Starts
- 2010-06-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2014-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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