RecruitingNot Applicable

B.Brilliant Revelation Comparision Study

United States100 participantsStarted 2025-12-15

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Comparison of two Siemen System B.brillant and the Revelation

Timeframe: From enrollment to the end of study at 18 months

Trial details

NCT IDNCT07067788

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-30

Contact for this trial

Namaijah Faison Clinical Research Coordinator

215-432-5000 Namaijah.Faison@pennmedicine.upenn.edu

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