B.Brilliant Revelation Comparision Study

NCT ID: NCT07067788

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-01-30

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

Conditions

Breast Cancer Screening

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Breast Imaging

Intervention Type: DIAGNOSTIC_TEST

Intervention using an FDA-approved mammogram machine.

Interventions

Breast Imaging

Intervention using an FDA-approved mammogram machine.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Siemens Corporation, Corporate Technology

INDUSTRY

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian S Englander, MD

Role: PRINCIPAL_INVESTIGATOR

Pennsylvania Hospital

Locations

Pennsylvania Hospital, Center for Breast Imaging

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Project Manager

Role: CONTACT

Jessica.Nunez@pennmedicine.upenn.edu

215-829-3712

Facility Contacts

Jessica Nunez

Role: primary

Jessica.Nunez@pennmedicine.upenn.edu

215-829-3712

Kamryn Delaney, BS

Role: backup

Kamryn.Delaney@pennmedicine.upenn.edu

215-573-9037

Other Identifiers

857586

Identifier Type: -

Identifier Source: org_study_id