Clinical trial NCT00591864: Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Official title: Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Benign breast disease
Breast
MRI
Mammography
Ultrasound
Molecular Breast Imaging
Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-01-11
Enrollment: 89
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity on the Per Patient Level
timeFrame: within 1 week of surgery or biopsy
Secondary outcomes:
measure: Sensitivity on the Per Tumor Level
timeFrame: within 1 week of surgery or biopsy
measure: Specificity
timeFrame: at least one year following imaging
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: