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B.Brilliant Revelation Comparision Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the MAMMOMAT B.brilliant breast imaging system in adults assigned female at birth who need breast X-rays for suspicious calcium deposits. The study observes imaging, and the treating doctor makes all diagnosis decisions using usual images from FDA-approved devices.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You were assigned female at birth.
  • You are having a diagnostic mammogram (breast X-ray) for suspicious calcium deposits or calcium deposits found with other breast changes.
  • You understand that the study is research and agree in writing to take part before any study procedures.

Who can't join

  • You are breastfeeding.
  • You are pregnant. If you could become pregnant, you must confirm that you are not pregnant.
  • A study doctor or your treating doctor thinks you cannot tolerate the imaging procedures.
  • A study doctor thinks a current health condition could make the study unsafe for you or keep you from taking part successfully.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

PA