Recruiting
Phase 1

99mTc-Glycopeptide

Sponsor:

SeeCure LLC

Code:

NCT01159405

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiolabeled (99mTc) GP (Glycopeptide)

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT01159405

Start date

Jun, 2010

Status verified date

Jul, 2014

Completion date

Apr, 2015

Anticipated

Primary completion date

Mar, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

9 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 99mTc-GP

99mTc-GP with SPECT/CT imaging \& whole body scan.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ning Tsao, PhD

7135719410ning.tsao@seecurellc.com

Chung Wei Huang, Master

7135719410huangchungwei@seecurellc.com

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Eileen Dickman, PhD, MBA, CCRC

713-441-9777edickman@houstonmethodist.org

Andrea Dotting, M.D

713-441-8029andotting@houstonmethodist.org

Principal Investigator:

Tejal Patel, M.D.

More Information

Sponsor

SeeCure LLC

Last update posted

Jul 30, 2014

Last verified

Jul, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SeeCure LLC on 2014-07-30.