Clinical Trials

Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Location:

Trial status:

Inactive

Why is this study being done?

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.

Who is eligible to participate?

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 augmentation.

- They have undergone breast surgery within the previous year

Last updated: 02/13/2013

NCT ID:

NCT00591864