Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts (MBI-DBT)
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|ClinicalTrials.gov Identifier: NCT03220893|
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Diagnostic Test: Molecular Breast Imaging Diagnostic Test: Digital Breast Tomosynthesis|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Comparison of Molecular Breast Imaging and Digital Breast Tomosynthesis for Screening in Women With Dense Breasts|
|Actual Study Start Date :||June 12, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Women with Dense Breast Tissue
Subjects will have had heterogeneously dense or extremely dense breasts on most recent prior mammographic examination (Breast Imaging Reporting and Data System (BI-RADS) c or d) and be asymptomatic for breast disease.
Subjects will receive Molecular Breast Imaging (MBI) and Digital Breast Tomosynthesis (DBT) at Year 0 screening within a 24-hour period. All patients who did not receive a diagnosis of breast cancer during the Year 0 screening will undergo DBT and MBI at approximately one year (Year 1 screening), again within a 24-hour period.
Diagnostic Test: Molecular Breast Imaging
Molecular breast imaging (MBI) is a new nuclear medicine technique that utilizes small semiconductor-based γ-cameras in a mammographic configuration to provide high-resolution functional images of the breast.
Diagnostic Test: Digital Breast Tomosynthesis
Digital Breast Tomosynthesis (DBT) creates a three dimensional picture of the breast using X-rays.
- Rate of detection of invasive cancers between DBT and MBI at Year 0 using the biopsy results (if available) and one-year follow-up results as the reference standard. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220893
|Contact: Tamara K Evans||507-266-1944||RSTDOMCTU@mayo.edu|
|Contact: Peggy Nordine||507-266-1944||RSTDOMCTU@mayo.edu|
|Principal Investigator:||Deborah Rhodes, MD||Mayo Clinic|