Clinical trial NCT01159405: The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Official title: A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: SeeCure LLC
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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.

Primary outcomes:
measure: To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.
timeFrame: from 99mTc-GP injection through 30 days
Secondary outcomes:
measure: 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.
timeFrame: from 99mTc-GP injection through 30 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas
name: Tejal Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: