Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- Mayo Clinic
- Study ID
- NCT03220893
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Digital Breast Tomosynthesis (DBT) — PROCEDUREDBT is standard of care breast screening
- Scintimammography — RADIATIONUndergo MBI
Study Details
This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.
Key Dates
- Start date
- Jun 14, 2017
- Status verified
- Jan 2026
- Primary completion
- Sep 30, 2024
- Completion
- Nov 1, 2024
Study Design
- Enrollment
- 3,023 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: DBT aloneAll participants undergo DBT screening
- Experimental: DBT + MBIAll participants undergo DBT screening + supplemental MBI
Primary Outcome Measure
Rate of Detection of Invasive Cancers [ Time Frame: At year 1 screening ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | - |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
| Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | 43623 | - |
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | - |
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