Breast Cancer Screening
Conditions
Keywords
breast, mammogram, breast cancer, female
Brief 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
Detailed description
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 Pennsylvania Hospital. The research scans required for this study will include either 5-8 seconds or 25 seconds of compression in two views (MLO & CC) of the affected breast (breast with suspicious calcifications at screening). Data will be collected to evaluate image quality regarding the visibility of calcifications. This study seeks to evaluate MAMMOMAT B.brilliant, which has decreased acquisition time and increased conspicuity of calcifications, as a replacement to standard wide-angle imaging as on the MAMMOMAT Revelation. 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
Interventions
DIAGNOSTIC_TESTBreast Imaging
Intervention using an FDA-approved mammogram machine.
Sponsors
University of Pennsylvania
Siemens Corporation, Corporate Technology
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of two Siemen System B.brillant and the Revelation | From enrollment to the end of study at 18 months | • 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Calcifications and patient survey | From enrollment to the end of study at 18 months | • 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. |
| Assessing the pain on two standard mammogram scanners | From enrollment to the end of study at 18 months | 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 |
Countries
United States
Contacts
CONTACTNamaijah Faison Clinical Research Coordinator
CONTACTJessica Nunez Project Manager
PRINCIPAL_INVESTIGATORBrian S Englander, MD
Pennsylvania Hospital
Outcome results
None listed