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

This study is currently recruiting participants.
Verified December 2013 by SeeCure LLC
Sponsor:
Information provided by (Responsible Party):
SeeCure LLC
ClinicalTrials.gov Identifier:
NCT01159405
First received: July 8, 2010
Last updated: December 9, 2013
Last verified: December 2013
  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.


Condition Intervention Phase
Breast Cancer
Radiation: Radiolabeled (99mTc) GP (Glycopeptide)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by SeeCure LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: from 99mTc-GP injection through 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 99mTc-GP
99mTc-GP with SPECT/CT imaging & whole body scan.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159405

Contacts
Contact: Ning Tsao, PhD 7135719410 ning.tsao@seecurellc.com
Contact: Chung Wei Huang, Master 7135719410 huangchungwei@seecurellc.com

Locations
United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Isis Gayed, M.D    713-704-1787    isis.w.gayed@uth.tmc.edu   
Contact: Vicki Ephron, M.D    832-265-6329    Vicki.J.Ephron@uth.tmc.edu   
Principal Investigator: Isis Gayed, M.D         
Sponsors and Collaborators
SeeCure LLC
Investigators
Principal Investigator: Isis Gayed, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: SeeCure LLC
ClinicalTrials.gov Identifier: NCT01159405     History of Changes
Obsolete Identifiers: NCT01374529
Other Study ID Numbers: SeeCure GP-001
Study First Received: July 8, 2010
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014