Recruiting
B.Brilliant Revelation Comparision Study
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
ClinicalTrials.gov IDNCT07067788
PhaseNot Applicable
Enrollment100
SponsorUniversity of Pennsylvania
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer Screening
About this study
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
Interventions
- Diagnostic Test: Breast Imaging — Intervention using an FDA-approved mammogram machine.
Primary outcomes
- Comparison of two Siemen System B.brillant and the Revelation (From enrollment to the end of study at 18 months)
Eligibility information
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.
Study locations
- Pennsylvania Hospital, Center for Breast Imaging, Philadelphia, Pennsylvania 19107 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.