B.Brilliant Revelation Comparision Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast Imaging.
- Who it may be relevant to
- Registry conditions: Breast Cancer Screening. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Diagnostic test Breast Imaging
Intervention using an FDA-approved mammogram machine.
Primary outcome measures
- Comparison of two Siemen System B.brillant and the Revelation [Time frame: From enrollment to the end of study at 18 months]
Secondary outcome measures (2)
- Accuracy of Calcifications and patient survey [Time frame: From enrollment to the end of study at 18 months]
- Assessing the pain on two standard mammogram scanners [Time frame: From enrollment to the end of study at 18 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Pennsylvania Hospital, Center for Breast Imaging — Philadelphia
Identifiers
NCT: NCT07067788 · 857586