Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
May 1, 2025 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University
PET Imaging of Breast Cancer Using Oncogene Expression
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.
Study Overview
Status
Terminated
Conditions
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: F-18-FDG Whole body Scan
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.
|
Undergo PEM Positron Emission Mammography scan
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
|
|
Experimental: No F-18-FDG Scan
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.
|
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
Undergo PET Positron Emission Tomography scan
Other Names:
|
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
Time Frame: 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).
|
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)
Time Frame: 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.
|
4 hours after Cu 64 TP3805 administered
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Madhukar Thakur, PhD, Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 8, 2016
First Submitted That Met QC Criteria
June 22, 2016
First Posted (Estimated)
June 23, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2025
Last Update Submitted That Met QC Criteria
May 1, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Skin Diseases
- Breast Diseases
- Breast Neoplasms
- Anti-Infective Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites
- Antiviral Agents
- Radiopharmaceuticals
- Trace Elements
- Micronutrients
- Fluorodeoxyglucose F18
- Deoxyglucose
- Copper
Other Study ID Numbers
- 08F.327
- JT 1419 (Other Identifier: JeffTrial Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
Yes
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