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

University of Pittsburgh

Status

Completed

Conditions

Breast Abnormalities

Treatments

Device: molecular breast imaging (Discovery)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01687790

PRO12030005

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.