Breast Cancer ScreeningNCT07067788
B.Brilliant Revelation Comparision Study
An observational study of Breast Cancer Screening, run by University of Pennsylvania at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Breast Imaging
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Namaijah Faison Clinical Research Coordinator contact
United States1 site, 1 recruiting
- Recruiting
Pennsylvania Hospital, Center for Breast Imaging
Philadelphia, Pennsylvania, 19107
Jessica Nunez, 215-829-3712, Jessica.Nunez@pennmedicine.upenn.edu
Namaijah Faison, MPH, 267-432-5000, Namaijah.Faison@pennmedicine.upenn.edu
About this study
Official title: A Clinical Comparison of Siemens Mammomat B.Brilliant , A Novel Wide-Angel Digitial Breast Tomosynthesis System With Siemens Mammomat Revelation , A Standard Wide-Angle Digital Breast Tomosynthesis System
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
Read the 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
- Conditions
- Breast Cancer Screening
- Being tested
- Breast Imaging
- Keywords
- breast, mammogram, breast cancer, female
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast ImagingDiagnostic test
Intervention using an FDA-approved mammogram machine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Breast Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study at 18 months
Secondary outcomes (2)
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.
Measured: From enrollment to the end of study at 18 months
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
Measured: From enrollment to the end of study at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Dec 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Sponsor
- Investigators
- Brian S Englander, MD, Principal investigator, Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067788
- Sponsor's protocol ID
- 857586
- Status last verified
- Apr 2026
- First submitted
- 12 May 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparison of Siemens Mammomat B.Brilliant , A Novel Wide-Angel Digitial Breast Tomosynthesis System With Siemens Mammomat Revelation , A Standard Wide-Angle Digital Breast Tomosynthesis System
- ClinicalTrials.gov ID
- NCT07067788
- Acronym / sponsor ID
- 857586
- Conditions
- Breast Cancer Screening
- Keywords
- breast, mammogram, breast cancer, female
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast imaging in Females | – | Diagnostic Test: Breast ImagingFemales 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast ImagingIntervention using an FDA-approved mammogram machine. | Diagnostic test | Breast imaging in Females |
Primary outcome
Comparison of two Siemen System B.brillant and the Revelation
Time frame: 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.
2 secondary outcomes
Accuracy of Calcifications and patient survey
Time frame: From enrollment to the end of study at 18 months
Assessing the pain on two standard mammogram scanners
Time frame: From enrollment to the end of study at 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Namaijah Faison Clinical Research Coordinator contact
Brian S Englander, MD principal investigator
Pennsylvania Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Screening, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namaijah Faison Clinical Research Coordinator (215-432-5000, Namaijah.Faison@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of two Siemen System B.brillant and the Revelation (time frame: From enrollment to the end of study at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.