Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System (MRI-PEM)

The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: MRI + PEM image

Detailed Description

70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female over 21 years of age;
• with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
• and in good health (other than having breast lesions);
• and can lie still in a prone position for 30 minutes in an MRI scanner.

Exclusion Criteria:

• Pregnancy;
• unwilling to give informed consent;
• have implanted prosthetic heart valve,
• pacemaker,
• neurostimulator,
• surgical clips or other metallic implants;
• have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
• are claustrophobic;
• have been allergic to contrast agents;
• are diabetic;
• or have a history of kidney disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Diagnostic accuracy with MRI alone; The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments.
Experimental: Diagnostic accuracy with MRI + PEM image; The combined PEM/MRI image will be examined.	Device: MRI + PEM image; Effect of positron emission mammography on diagnostic accuracy; Other Names: flurodeoxyglucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)	Patients with benign disease on biopsy may be followed for up to 2 years after imaging	up to 2 years

Collaborators and Investigators

• Sponsor: Weinberg Medical Physics LLC
• Collaborators: University of California, Irvine
• Investigators: Principal Investigator: Irving Weinberg, MD PhD, Weinberg Medical Physics LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): May 8, 2016
• Study Completion (Actual): May 8, 2016

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: WMP-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No