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

July 8, 2010
December 9, 2013
June 2010
December 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01159405 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
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
Experimental: 99mTc-GP
99mTc-GP with SPECT/CT imaging & whole body scan.
Intervention: Radiation: Radiolabeled (99mTc) GP (Glycopeptide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Ning Tsao, PhD 7135719410 ning.tsao@seecurellc.com
Contact: Chung Wei Huang, Master 7135719410 huangchungwei@seecurellc.com
United States
 
NCT01159405
SeeCure GP-001
No
SeeCure LLC
SeeCure LLC
Not Provided
Principal Investigator: Isis Gayed, M.D. The University of Texas Health Science Center, Houston
SeeCure LLC
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP