Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT07067788

Conditions

Breast Cancer Screening

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Breast Imaging

Study Details

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

Study ID

NCT07067788

Start date

Dec 15, 2025

Status verified date

Apr, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Breast Imaging

Intervention using an FDA-approved mammogram machine.

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 ]

Central Contacts and Locations

Central contacts

Namaijah Faison Clinical Research Coordinator

215-432-5000Namaijah.Faison@pennmedicine.upenn.edu

Jessica Nunez Project Manager

215-829-3712Jessica.Nunez@pennmedicine.upenn.edu

Locations

Pennsylvania Hospital, Center for Breast Imaging

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Jessica Nunez

215-829-3712Jessica.Nunez@pennmedicine.upenn.edu

Namaijah Faison, MPH

267-432-5000Namaijah.Faison@pennmedicine.upenn.edu

Principal Investigator:

Brian S. Englander, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • breast
  • mammogram
  • breast cancer
  • female

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-04-24.