NCT07067788

B.Brilliant Revelation Comparision Study

A Clinical Comparison of Siemens Mammomat B.Brilliant , A Novel Wide-Angel Digitial Breast Tomosynthesis System With Siemens Mammomat Revelation , A Standard Wide-Angle Digital Breast Tomosynthesis System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices

Detailed description

Women scheduled at Pennsylvania Hospital to undergo a standard of care diagnostic imaging exam after having had a standard of care screening exam performed on either the MAMMOMAT B.brilliant (NDBT) or the MAMMOMAT Revelation (DBT) mammography system with findings consistent with suspicious calcifications or calcifications associated with other lesion types will be eligible and approached to enroll in the study. Participants must be ≥ 18 years of age. Up to 125 evaluable participants will be enrolled. Eligible and consented participants enrolled in the study will receive standard of care diagnostic imaging on the same mammography system as the screening exam and receive two additional research images on the other mammography system. Both mammographic units are FDA approved and located at Pennsylvania Hospital. The research scans required for this study will include either 5-8 seconds or 25 seconds of compression in two views (MLO \& CC) of the affected breast (breast with suspicious calcifications at screening). Data will be collected to evaluate image quality regarding the visibility of calcifications. This study seeks to evaluate MAMMOMAT B.brilliant, which has decreased acquisition time and increased conspicuity of calcifications, as a replacement to standard wide-angle imaging as on the MAMMOMAT Revelation. This is an observational study to evaluate the MAMMOMAT B.brilliant system. All diagnostic decisions are made by the treating radiologist based upon standard of care clinical imaging acquired on FDA approved devices

Conditions

• Breast Cancer Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Breast Imaging	Intervention using an FDA-approved mammogram machine.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-07-30
• Completion: 2027-01-30
• First posted: 2025-07-16
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study