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

Weinberg Medical Physics

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: MRI + PEM image

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02426489

WMP-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Diagnostic accuracy with MRI alone

No Intervention group

Description:

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.

Diagnostic accuracy with MRI + PEM image

Experimental group

Description:

The combined PEM/MRI image will be examined.

Treatment:

Device: MRI + PEM image