B.Brilliant Revelation Comparision Study
Sponsored by University of Pennsylvania
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
Women scheduled at Pennsylvania Hospital to undergo a standard of care diagnostic imaging exam after having had a standard of care screening exam performed on either the MAMMOMAT B.brilliant (NDBT) or the MAMMOMAT Revelation (DBT) mammography system with findings consistent with suspicious calcifications or calcifications associated with other lesion types will be eligible and approached to enroll in the study. Participants must be ≥ 18 years of age. Up to 125 evaluable participants will be enrolled. Eligible and consented participants enrolled in the study will receive standard of care diagnostic imaging on the same mammography system as the screening exam and receive two additional research images on the other mammography system. Both mammographic units are FDA approved and located at …
Where this study is enrolling
- I'm interested
Pennsylvania Hospital, Center for Breast Imaging
Philadelphia, Pennsylvania
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.