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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MRI + PEM image


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Diagnostic accuracy with MRI alone<br>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<br>The combined PEM/MRI image will be examined. | Device: MRI + PEM image<br>* Effect of positron emission mammography on diagnostic accuracy<br>* Other names: flurodeoxyglucose;|

What is the study measuring?
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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 |