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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01159405
• Other study ID #: SeeCure GP-001
• Status: Recruiting
• Phase: Phase 1
• First received: July 8, 2010
• Last updated: July 29, 2014
• Start date: June 2010
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: SeeCure LLC
• Contact: Ning Tsao, PhD
• Phone: 7135719410
• Email: ning.tsao[@]seecurellc.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01374529

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Radiolabeled (99mTc) GP (Glycopeptide)
one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg & 20 mg of GP will be injected

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
SeeCure LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes