B.Brilliant Revelation Comparision Study

NCT07067788 | Recruiting FDA Device

• 1 other identifier: 857586
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer Screening

Keywords

breast; mammogram; breast cancer; female

Outcome Measures

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.

  From enrollment to the end of study at 18 months

Secondary Outcomes (2)

• Accuracy of Calcifications and patient survey

  From enrollment to the end of study at 18 months

• Assessing the pain on two standard mammogram scanners

  From enrollment to the end of study at 18 months

Study Arms (1)

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.

Diagnostic Test: Breast Imaging

Interventions

Breast Imaging DIAGNOSTIC_TEST

Intervention using an FDA-approved mammogram machine.

Breast imaging in Females

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: females whose gender is assigned at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

Pennsylvania Hospital, Center for Breast Imaging

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brian S Englander, MD

  Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 16, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)