Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation (MBI)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular Breast Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer
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
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sensitivity on the Per Tumor Level
Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
Specificity
The number of women with negative imaging test per number of women without cancer.
Full Information
NCT ID
NCT00591864
First Posted
December 21, 2007
Last Updated
June 6, 2014
Sponsor
Mayo Clinic
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT00591864
Brief Title
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Acronym
MBI
Official Title
Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Molecular Breast Imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity on the Per Patient Level
Description
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 Outcome Measure Information:
Title
Sensitivity on the Per Tumor Level
Description
Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
Time Frame
within 1 week of surgery or biopsy
Title
Specificity
Description
The number of women with negative imaging test per number of women without cancer.
Time Frame
at least one year following imaging
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials
URL
http://newsblog.mayoclinic.org/2008/09/03/breast-cancer-molecular-breast-imaging-mammography/
Description
Mayo Clinic News Blog
URL
http://www.youtube.com/watch?v=DOQBLe8MdH0
Description
Mayo Clinic You Tube Channel
Learn more about this trial
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
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