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

NCT ID: NCT02426489

Last Updated: 2021-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2016-05-08

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Diagnostic accuracy with MRI + PEM image

The combined PEM/MRI image will be examined.

Group Type: EXPERIMENTAL

MRI + PEM image

Intervention Type: DEVICE

Effect of positron emission mammography on diagnostic accuracy

Interventions

MRI + PEM image

Effect of positron emission mammography on diagnostic accuracy

Intervention Type: DEVICE

Other Intervention Names

flurodeoxyglucose

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

Weinberg Medical Physics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irving Weinberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Weinberg Medical Physics LLC

Other Identifiers

WMP-2

Identifier Type: -

Identifier Source: org_study_id