Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
PET Imaging of Breast Cancer Using Oncogene Expression

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Device: Positron Emission Mammography
* Device: Positron Emission Tomography
* Radiation: Fludeoxyglucose F-18
* Drug: Copper Cu 64 TP3805


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan) Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI) Signed informed consent form approved by the institutional review board (IRB) Exclusion Criteria: Pregnant or lactating female Patient with asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F-18-FDG Whole body Scan<br>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. | Device: Positron Emission Mammography<br>* Undergo PEM Positron Emission Mammography scan<br>Radiation: Fludeoxyglucose F-18<br>* Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan<br>* Other names: Fluorodeoxyglucose F18;Drug: Copper Cu 64 TP3805<br>* Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan<br>* Other names: Cu-64-TP3805;|
| Experimental: No F-18-FDG Scan<br>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. | Device: Positron Emission Tomography<br>* Undergo PET Positron Emission Tomography scan<br>* Other names: proton magnetic resonance spectroscopic imaging;Radiation: Fludeoxyglucose F-18<br>* Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan<br>* Other names: Fluorodeoxyglucose F18;Drug: Copper Cu 64 TP3805<br>* Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan<br>* Other names: Cu-64-TP3805;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog | Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient). | 4 hours after Cu 64 TP3805 administered | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity) | Optimal imaging time is the one (of the three) which will have least background activity in the surrounding tissue and image the maximum number of lesions with clarity. 95% confidence intervals will be used. To account for the multiplicity of lesions per patient, the GEE approach will be used, with the robust variance. Any adverse events will be summarized descriptively. | 4 hours after Cu 64 TP3805 administered |