Houston, Texas 77030


Purpose:

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.


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.


NCT ID:

NCT01159405


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.