NCT03220893

Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue

Density MATTERS [Molecular Breast Imaging (MBI) And Tomosynthesis To Eliminate the ReServoir]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,023 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This study includes women age 40-75 who are presenting for breast cancer screening and had mammographically dense breasts on their last mammogram. Participants undergo annual DBT and MBI screening for two years. The primary aim for this study is to compare the rate of detection of invasive cancers between DBT alone vs. the combination of DBT with supplemental MBI at the first year of screening.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Digital Breast Tomosynthesis (DBT)	DBT is standard of care breast screening
RADIATION	Scintimammography	Undergo MBI

Timeline

• Start date: 2017-06-14
• Primary completion: 2024-09-30
• Completion: 2024-11-01
• First posted: 2017-07-18
• Last updated: 2026-02-20
• Results posted: 2026-02-03

Locations

5 sites across 1 country: United States