Clinical trial · Observational
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
NCT07067788CI-TRIAL-00109336recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Screening | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast imaging in Females
- description
- 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.
- interventionNames
- Diagnostic Test: Breast Imaging
Primary outcomes (1)
- measure
- Comparison of two Siemen System B.brillant and the Revelation
- timeFrame
- From enrollment to the end of study at 18 months
- description
- • To assess whether the MAMMOMAT B.brilliant, a Novel Wide-Angle Digital Breast Tomosynthesis (NDBT) System, leads to better visualization of calcifications compared to the MAMMOMAT Revelation, a standard wide-angle Digital Breast Tomosynthesis (DBT) System, including the assessment of calcifications on synthetic images for both tomosynthesis scans.
Secondary outcomes (2)
- measure
- Accuracy of Calcifications and patient survey
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.