Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation (MBI)

Mayo Clinic

Status

Completed

Conditions

Breast Cancer

Treatments

Device: Molecular Breast Imaging

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00591864

07-003397

Details and patient eligibility

About

The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.

Full description

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.

Enrollment

89 patients

Sex

Female

Ages

25+ years old

Volunteers

No Healthy Volunteers

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