RecruitingNCT07067788

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

Sponsor

University of Pennsylvania

Enrollment

100 participants

Start Date

Dec 15, 2025

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Screening

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

Participants will be ≥ 18 years of age.
Participants will be females (sex assigned at birth).
Participants will be presenting for clinical diagnostic mammography with suspicious calcifications or calcifications associated with other lesion types
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 Criteria4

Females who are breast-feeding will not be eligible for this study
Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant.
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
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.