Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Mayo Clinic89 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Breast Cancer

Interventions

Molecular Breast ImagingDEVICE

Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Sensitivity on the Per Patient Level

Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.

Time frame: within 1 week of surgery or biopsy

Secondary Outcomes

Sensitivity on the Per Tumor Level

Number of tumors detected per number of tumors diagnosed on surgery or biopsy.

Time frame: within 1 week of surgery or biopsy

Specificity

The number of women with negative imaging test per number of women without cancer.

Time frame: at least one year following imaging

Data from ClinicalTrials.gov

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