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

December 11, 2017 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

Intervention / Treatment

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

Genders Eligible for Study

Female

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.
Device: Positron Emission Mammography
Undergo PEM Positron Emission Mammography scan
Radiation: Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • 18FDG
  • FDG
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 105851-17-0
  • 723398
Drug: Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • Cu-64-TP3805
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.
Radiation: Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • 18FDG
  • FDG
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
  • 2-Deoxy-2-(18F)Fluoro-D-Glucose
  • 2-F18-Fluoro-2-deoxy-D-glucose
  • 2-F18-Fluoro-2-deoxyglucose
  • 105851-17-0
  • 723398
Drug: Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Names:
  • Cu-64-TP3805
Device: Positron Emission Tomography
Undergo PET Positron Emission Tomography scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • proton magnetic resonance spectroscopic imaging

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.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

National Institutes of Health (NIH)

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 (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08F.327

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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