Conditions: Breast Carcinoma
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: no

Brief summary:
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.

Detailed description:
OBJECTIVES:

I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.

II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).

III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.

OUTLINE: This is a dose-finding 2-stage study.

STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.

STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.

Arms:
arm 1: STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan. arm 2: STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.

Interventions: intervention 1: Positron Emission Mammography intervention 2: Positron Emission Tomography intervention 3: Fludeoxyglucose F-18 intervention 4: Copper Cu 64 TP3805
Intervention descriptions: intervention 1: Undergo PEM Positron Emission Mammography scan intervention 2: Undergo PET Positron Emission Tomography scan intervention 3: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan intervention 4: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan

Protocol document: