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

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

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

- 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

- Patients with history of hypersensitivity/allergy to Chitosan/Chitin related
shellfish foods.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

from 99mTc-GP injection through 30 days

Safety Issue:


Principal Investigator

Isis Gayed, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston


United States: Food and Drug Administration

Study ID:

SeeCure GP-001



Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Memorial Hermann HospitalHouston, Texas  77030