Comparing the MAMMOMAT B.brilliant and Revelation mammography systems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Up to 125 women aged 18 or older who were found to have suspicious calcifications on a screening mammogram at Pennsylvania Hospital will be enrolled. Participants receive their standard diagnostic mammogram on the same system used for screening and then two additional research images on the alternate system. The study compares image quality and calcification visibility between the MAMMOMAT B.brilliant (shorter acquisition time) and the MAMMOMAT Revelation using paired views (MLO and CC) with either 5–8 second or 25 second compression sequences. All clinical decisions remain with the treating radiologist and both units are FDA‑approved and located at the Center for Breast Imaging at Pennsylvania Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pennsylvania Hospital, Center for Breast Imaging
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Brian S Englander, MD — Pennsylvania Hospital
• Study coordinator: Namaijah Faison Clinical Research Coordinator
• Email: Namaijah.Faison@pennmedicine.upenn.edu
• Phone: 215-432-5000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.