B.Brilliant Revelation Comparision Study
ConditionBreast Cancer Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Pennsylvania
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Breast Imaging
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pennsylvania
Lead sponsor
Siemens Corporation, Corporate Technology
Collaborator
Source ClinicalTrials.gov