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Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation

25 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation

Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low
specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients.
Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo.
Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm.
The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.

Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.

Study Design: A total of 120 patients will be studied. All patients will have been scheduled
for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving,
or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks
of the MRI examination.

Potential Outcomes: This study will provide valuable information on the sensitivity of MBI
relative to MRI, and to determine if this new technique can be eventually developed as an
alternative to MRI for problem solving.

Inclusion Criteria:

- This study will include a population of women aged 25 or older who are scheduled for
a breast MRI examination at MAYO CLINIC ROCHESTER.

- Patients must not be lactating or pregnant.

- All women of child-bearing potential must have had a negative urine pregnancy test
result within 2 days prior to the MBI study.

- women who are scheduled for a breast MRI examination for a clinical concern, problem
solving or for further evaluation of invasive breast cancer (e.g. pre-operative
staging of known breast cancer).

Exclusion Criteria:

- They are unable to understand and sign the consent form

- They are pregnant or lactating

- They are physically unable to sit upright and still for 40 minutes.

- The breast MRI is for screening purposes or to determine the status of breast

- They have undergone breast surgery within the previous year

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity of molecular breast imaging relative to MRI of the breast

Outcome Time Frame:

within 1 week of surgery or biopsy

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Benign breast disease
  • Breast
  • MRI
  • Mammography
  • Ultrasound
  • Molecular Breast Imaging
  • Breast Cancer
  • Breast Neoplasms



Mayo Clinic Rochester, Minnesota  55905