NCT02810873

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

PET Imaging of Breast Cancer Using Oncogene Expression

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	Positron Emission Mammography	Undergo PEM Positron Emission Mammography scan
DEVICE	Positron Emission Tomography	Undergo PET Positron Emission Tomography scan
RADIATION	Fludeoxyglucose F-18	Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
DRUG	Copper Cu 64 TP3805	Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2016-06-23
• Last updated: 2025-05-04
• Results posted: 2018-01-09

Regulatory

• FDA-regulated device study