The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer

Phase 1

• Conditions: Breast Cancer
• Interventions: Radiation: Radiolabeled (99mTc) GP (Glycopeptide)

• Registration Number: NCT01159405
• Lead Sponsor: SeeCure LLC

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 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30
• Primary Completion: 2015-03
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-GP	Radiolabeled (99mTc) GP (Glycopeptide)	99mTc-GP with SPECT/CT imaging \& whole body scan.

Primary Outcome Measures

Name	Time	Method
To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.	from 99mTc-GP injection through 30 days

Secondary Outcome Measures

Name	Time	Method
To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.	from 99mTc-GP injection through 30 days

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States