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



Status:Completed
Conditions:Breast Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:September 2012
End Date:September 2014
Contact:Melissa J Davis, RN
Email:davismj@upmc.edu
Phone:412-623-1053

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

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.


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.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15232
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from
Pittsburgh, PA
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