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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
molecular breast imaging	molecular breast imaging (Discovery)	-

Primary Outcome Measures

Name	Time	Method
Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.	1 year	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).

Secondary Outcome Measures

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