The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease

Study Overview
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Brief Summary
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The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.

Official Title
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The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.

Conditions
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Breast Abnormalities

Intervention / Treatment
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* Device: molecular breast imaging (Discovery)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy Exclusion Criteria: Known contraindication to mammographic imaging women who are pregnant women who are lactating women who have significant existing breast trauma women who have breast implants Women under 18 years of age. women who had previous benign breast surgery within 1 year Males and children Women who are unable to understand or execute written informed consent Women who refuse to have a biopsy Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: molecular breast imaging<br> | Device: molecular breast imaging (Discovery)<br> <br> * Other names: Discovery NM750b;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. | The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. | Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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molecular breast imaging, breast disease, breast biopsy