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

Not Applicable

Terminated

• Conditions: Breast Carcinoma
• Interventions: Device: Positron Emission Mammography; Device: Positron Emission Tomography; Radiation: Fludeoxyglucose F-18; Drug: Copper Cu 64 TP3805

• Registration Number: NCT02810873
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-23
• Results First Submitted: 2017-09-15
• Results First Submitted QC: 2017-12-11
• Results First Posted: 2018-01-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No F-18-FDG Scan	Copper Cu 64 TP3805	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.
F-18-FDG Whole body Scan	Copper Cu 64 TP3805	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.
F-18-FDG Whole body Scan	Positron Emission Mammography	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.
F-18-FDG Whole body Scan	Fludeoxyglucose F-18	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.
No F-18-FDG Scan	Positron Emission Tomography	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.
No F-18-FDG Scan	Fludeoxyglucose F-18	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.

Primary Outcome Measures

Name	Time	Method
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog	4 hours after Cu 64 TP3805 administered	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).

Secondary Outcome Measures

Name	Time	Method
Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)	4 hours after Cu 64 TP3805 administered	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.