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

18 Years
Open (Enrolling)
Breast Abnormalities

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Trial Information

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

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 GFR or glomerular filtration rate 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

specificity of MBI

Outcome Description:

We will compare the outcome of the biopsies with the determinations made with the MBI examinations. The rate of unnecessary biopsies will be determined by the specificity and prevalence of cancer in the dataset. Thus, we formulate our primary statistical hypothesis in terms of a reduction in the false positive frequency (namely an improvement in specificity) of the pre-biopsy diagnostic work-up that includes MBI.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Christiane Hakim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Breast Abnormalities
  • molecular breast imaging
  • breast disease
  • breast biopsy
  • Congenital Abnormalities
  • Breast Diseases



Hillman Cancer Center Pittsburg, Pennsylvania  15232