NCT02810873

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 9, 2018

Completed
Last Updated

May 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

June 8, 2016

Results QC Date

September 15, 2017

Last Update Submit

May 1, 2025

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog

    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 Outcomes (1)

  • Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)

    4 hours after Cu 64 TP3805 administered

Study Arms (2)

F-18-FDG Whole body Scan

EXPERIMENTAL

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 MammographyRadiation: Fludeoxyglucose F-18Drug: Copper Cu 64 TP3805

No F-18-FDG Scan

EXPERIMENTAL

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.

Device: Positron Emission TomographyRadiation: Fludeoxyglucose F-18Drug: Copper Cu 64 TP3805

Interventions

Positron Emission MammographyDEVICE

Undergo PEM Positron Emission Mammography scan

F-18-FDG Whole body Scan
Positron Emission TomographyDEVICE

Undergo PET Positron Emission Tomography scan

Also known as: Medical Imaging, Positron Emission Tomography, proton magnetic resonance spectroscopic imaging
No F-18-FDG Scan
Fludeoxyglucose F-18RADIATION

Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan

Also known as: 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 105851-17-0, 18FDG, 723398, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
F-18-FDG Whole body ScanNo F-18-FDG Scan
Copper Cu 64 TP3805DRUG

Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan

Also known as: Cu-64-TP3805
F-18-FDG Whole body ScanNo F-18-FDG Scan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Pregnant or lactating female
  • Patient with asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Positron-Emission TomographyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeDeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Dr. Mathew Thakur
Organization
Sidney Kimmel Cancer Center at Thomas Jefferson University
mathew.thakur@jefferson.edu
215-503-7874

Study Officials

  • Madhukar Thakur, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 23, 2016

Study Start

September 1, 2008

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

May 4, 2025

Results First Posted

January 9, 2018

Record last verified: 2025-05