Comparing the MAMMOMAT B.brilliant and Revelation mammography systems
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
University of Pennsylvania · NCT07067788
We will try two FDA‑approved mammogram machines to see which shows suspicious breast calcifications more clearly in women having diagnostic mammography.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07067788 on ClinicalTrials.gov |
What this trial studies
Up to 125 women aged 18 or older who were found to have suspicious calcifications on a screening mammogram at Pennsylvania Hospital will be enrolled. Participants receive their standard diagnostic mammogram on the same system used for screening and then two additional research images on the alternate system. The study compares image quality and calcification visibility between the MAMMOMAT B.brilliant (shorter acquisition time) and the MAMMOMAT Revelation using paired views (MLO and CC) with either 5–8 second or 25 second compression sequences. All clinical decisions remain with the treating radiologist and both units are FDA‑approved and located at the Center for Breast Imaging at Pennsylvania Hospital.
Who should consider this trial
Good fit: Women aged 18 or older who have suspicious calcifications on a screening mammogram performed on either the MAMMOMAT B.brilliant or Revelation system and who can provide informed consent are ideal candidates.
Not a fit: Pregnant or breastfeeding women, people without calcifications, those unable to tolerate compression, or those who cannot travel to Pennsylvania Hospital are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the B.brilliant approach could make calcifications easier to see while shortening scan time, which may improve diagnostic clarity and patient comfort.
How similar studies have performed: Other studies have compared different digital breast tomosynthesis and acquisition strategies, but the B.brilliant's specific short‑acquisition, increased‑conspicuity approach is relatively new and not yet widely published.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Participants will be ≥ 18 years of age. 2. Participants will be females (sex assigned at birth). 3. Participants will be presenting for clinical diagnostic mammography with suspicious calcifications or calcifications associated with other lesion types 4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria 1. Females who are breast-feeding will not be eligible for this study 2. Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant. 3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. 4. Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
Where this trial is running
Philadelphia, Pennsylvania
- Pennsylvania Hospital, Center for Breast Imaging — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Brian S Englander, MD — Pennsylvania Hospital
- Study coordinator: Namaijah Faison Clinical Research Coordinator
- Email: Namaijah.Faison@pennmedicine.upenn.edu
- Phone: 215-432-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Screening, breast, mammogram, breast cancer, female