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
This trial accepts healthy volunteersQualifiers
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 population
Women are coming back for diagnostic imaging, whose screening mammogram shows findings of calcifications or lesions with calcifications, who are equal to or greater than 18 years of age.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Breast Imaging
Diagnostic testIntervention using an FDA-approved mammogram machine.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Breast imaging in Females1 intervention
Trial outcomes
Primary outcomes
1
Comparison of two Siemen System B.brillant and the Revelation
• To assess whether the MAMMOMAT B.brilliant, a Novel Wide-Angle Digital Breast Tomosynthesis (NDBT) System, leads to better visualization of calcifications compared to the MAMMOMAT Revelation, a standard wide-angle Digital Breast Tomosynthesis (DBT) System, including the assessment of calcifications on synthetic images for both tomosynthesis scans.
Time frame
From enrollment to the end of study at 18 monthsSecondary outcomes
1
Accuracy of Calcifications and patient survey
• To evaluate the accuracy of B.brilliant for predicting the number of calcifications and extent of the calcification cluster(s) and morphology compared to standard wide-angle DBT (including synthetic images for both) with diagnostic magnification views as the gold standard.
Time frame
From enrollment to the end of study at 18 months2
Assessing the pain on two standard mammogram scanners
To assess whether subjects imaged with B.brilliant and standard wide-angle DBT perceive any difference in ease of exam or pain. We are using a numerical pain scale, a 0 to 5 point scale. 0 no pain and 5 severe pain
Time frame
From enrollment to the end of study at 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Siemens Corporation, Corporate Technology
Collaborator
Source ClinicalTrials.gov