Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00591864
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-11
• Study Start: 2008-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2014-03-07
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-06
• Last Update Submitted: 2014-06-06
• Results First Posted: 2014-07-09
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity on the Per Patient Level	within 1 week of surgery or biopsy	Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.

Secondary Outcome Measures

Name	Time	Method
Sensitivity on the Per Tumor Level	within 1 week of surgery or biopsy	Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
Specificity	at least one year following imaging	The number of women with negative imaging test per number of women without cancer.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States