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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159405
Recruitment Status : Unknown
Verified July 2014 by SeeCure LLC.
Recruitment status was:  Recruiting
First Posted : July 9, 2010
Last Update Posted : July 30, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiolabeled (99mTc) GP (Glycopeptide) Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
Study Start Date : June 2010
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01159405

Contact: Ning Tsao, PhD 7135719410
Contact: Chung Wei Huang, Master 7135719410

United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Eileen Dickman, PhD, MBA, CCRC    713-441-9777   
Contact: Andrea Dotting, M.D    713-441-8029   
Principal Investigator: Tejal Patel, M.D.         
Sub-Investigator: Angel Rodriguez, M.D.         
Sub-Investigator: Daniel Y. Lee, M.D., Ph.D.         
Sub-Investigator: Jenny C-N Chang, M.B.BChir, M.D.         
Sponsors and Collaborators
SeeCure LLC
Principal Investigator: Tejal Patel, M.D. Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas

Responsible Party: SeeCure LLC Identifier: NCT01159405     History of Changes
Obsolete Identifiers: NCT01374529
Other Study ID Numbers: SeeCure GP-001
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

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