The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Radiolabeled (99mTc) GP (Glycopeptide)
Type: Radiation
Overall Status
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.
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Houston Methodist Hospital
Houston, Texas, United States
Status: Recruiting
Contact: Eileen Dickman, PhD, MBA, CCRC - 713-441-9777 -
Start Date
June 2010
Completion Date
April 2015
SeeCure LLC
SeeCure LLC
Record processing date processed this data on July 28, 2015 page