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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast imaging in Females | Females who are equal to or greater than 18 years of age are scheduled to have additional imaging due to findings of calcifications or lesions with calcifications on a screening mammogram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Imaging | Diagnostic Test | Intervention using an FDA-approved mammogram machine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of study at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of study at 18 months |
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Inclusion Criteria
Exclusion Criteria
females whose gender is assigned at birth.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Namaijah Faison Clinical Research Coordinator | Contact | 215-432-5000 | Namaijah.Faison@pennmedicine.upenn.edu | |
| Jessica Nunez Project Manager | Contact | 215-829-3712 | Jessica.Nunez@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian S Englander, MD | Pennsylvania Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital, Center for Breast Imaging | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 | From enrollment to the end of study at 18 months |
| D017437 |
| Skin and Connective Tissue Diseases |