Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Study Overview
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Brief Summary
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The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.

Detailed Description
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Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of  88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination. Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost. Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination. Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.

Official Title
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Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Molecular Breast Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER. Patients must not be lactating or pregnant. All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study. women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer). Exclusion Criteria: They are unable to understand and sign the consent form They are pregnant or lactating They are physically unable to sit upright and still for 40 minutes. The breast MRI is for screening purposes or to determine the status of breast augmentation. They have undergone breast surgery within the previous year

Ages Eligible for Study
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Minimum Age: 25 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity on the Per Patient Level | Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy. | within 1 week of surgery or biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity on the Per Tumor Level | Number of tumors detected per number of tumors diagnosed on surgery or biopsy. | within 1 week of surgery or biopsy | 
| Specificity | The number of women with negative imaging test per number of women without cancer. | at least one year following imaging | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer