Houston, Texas 77030


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.

Study summary:

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.


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.



Primary Contact:

Principal Investigator
Tejal Patel, M.D.
Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas

Ning Tsao, PhD
Phone: 7135719410
Email: ning.tsao@seecurellc.com

Backup Contact:

Email: huangchungwei@seecurellc.com
Chung Wei Huang, Master
Phone: 7135719410

Location Contact:

Houston, Texas 77030
United States

Eileen Dickman, PhD, MBA, CCRC
Phone: 713-441-9777
Email: edickman@houstonmethodist.org

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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