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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Terminated

Conditions: Breast Carcinoma

Treatments: Device: Positron Emission Tomography; Device: Positron Emission Mammography; Radiation: Fludeoxyglucose F-18; Drug: Copper Cu 64 TP3805

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02810873

08F.327

JT 1419 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups

F-18-FDG Whole body Scan

Experimental group

Description:

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.

Treatment:

Drug: Copper Cu 64 TP3805

Radiation: Fludeoxyglucose F-18

Device: Positron Emission Mammography

No F-18-FDG Scan

Experimental group

Description:

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.

Treatment:

Drug: Copper Cu 64 TP3805

Radiation: Fludeoxyglucose F-18

Device: Positron Emission Tomography