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

Breast Carcinoma Clinical Trial

Official title:

PET Imaging of Breast Cancer Using Oncogene Expression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02810873
• Other study ID #: 08F.327
• Status: Terminated
• Phase: N/A
• First received: June 8, 2016
• Last updated: December 11, 2017
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: December 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Device:
• Positron Emission Mammography
Undergo PEM Positron Emission Mammography scan
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)	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

External Links

•   Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
•   Thomas Jefferson University Hospital