Actively Recruiting
A Clinical Comparison of Siemens Mammomat B.Brilliant, a Novel Wide-Angle Digital Breast Tomosynthesis System, with Siemens Mammomat Revelation, a Standard Wide-Angle Digital Breast Tomosynthesis System
Led by University of Pennsylvania · Updated on 2026-04-24
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
S
Siemens Corporation, Corporate Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the MAMMOMAT B.brilliant system, a new wide-angle digital breast tomosynthesis imaging device, in women undergoing breast cancer screening with suspicious calcifications. The study compares this novel system to the standard MAMMOMAT Revelation system, both FDA approved, to assess image quality and visibility of calcifications. The study is observational and involves women 18 years or older who require additional diagnostic imaging after screening. Participants will receive standard diagnostic mammography using the same machine as their screening exam, either the MAMMOMAT B.brilliant or the MAMMOMAT Revelation. In addition, they will have two research images taken on the alternate system. The research scans will include compression of the affected breast for 5-8 or 25 seconds in two views to collect data on image quality and calcification visibility. During the study, women will undergo these imaging procedures and may complete patient surveys assessing pain and comfort. Researchers will compare the two imaging systems over an 18-month period, focusing on the accuracy of detecting calcifications and patient experience. All diagnostic decisions will follow standard care protocols. The total study duration for each participant extends to 18 months from enrollment.
CONDITIONS
Brief Title
B.Brilliant Revelation Comparision Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older
- Participants must be females (sex assigned at birth)
- Participants must be scheduled for clinical diagnostic mammography with suspicious calcifications or calcifications linked to other lesion types
- Participants must understand the investigational nature of the study and provide written informed consent prior to procedures
You will not qualify if you...
- Females who are breastfeeding are not eligible
- Pregnant women are excluded; all females of childbearing potential must confirm they are not pregnant
- Participants unable to tolerate imaging procedures, as determined by the investigator or physician, are excluded
- Any medical condition or illness that could compromise safety or successful participation as assessed by a physician investigator excludes participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo standard of care diagnostic imaging using the same mammography system as the screening exam, along with two additional research images on the alternate mammography system.
1 visit (in-person)
Duration - Up to 18 months
Participants are observed for up to 18 months to evaluate image quality, accuracy of calcification detection, and patient experience.
Follow-up assessments as needed
Trial Site Locations
Total: 1 location
1
Pennsylvania Hospital, Center for Breast Imaging
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
N
Namaijah Faison Clinical Research Coordinator
J
Jessica Nunez Project Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here