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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by SeeCure LLC
Sponsor:
Information provided by (Responsible Party):
SeeCure LLC
ClinicalTrials.gov Identifier:
NCT01159405
First received: July 8, 2010
Last updated: July 29, 2014
Last verified: July 2014
  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: April 2015
Estimated Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Eileen Dickman, PhD, MBA, CCRC    713-441-9777    edickman@houstonmethodist.org   
Contact: Andrea Dotting, M.D    713-441-8029    andotting@houstonmethodist.org   
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
Investigators
Principal Investigator: Tejal Patel, M.D. Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
  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: July 29, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014