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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiolabeled (99mTc) GP (Glycopeptide)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 99mTc-GP<br>99mTc-GP with SPECT/CT imaging & whole body scan. | Radiation: Radiolabeled (99mTc) GP (Glycopeptide)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios. |  | from 99mTc-GP injection through 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | from 99mTc-GP injection through 30 days |