Clinical trial · Observational
Acquisition of Breast Mammography Images
Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
NCT02156258CI-TRIAL-00045172completedResults postedClinicalTrials.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 a case collection study of breast images using standard and new mammography technology.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DBT Mammography | Device | — | UNRESOLVED |
| FFDM Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Diagnostic Cases
- description
- Collection of cases that were scheduled for biopsy (BI-RADS 4 or 5) using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
- interventionNames
- Device: FFDM Mammography
- Device: DBT Mammography
- label
- Recall Cases
- description
- Collection of Imaging Recall Cases (were scheduled for additional imaging due an assessment of BI-RADS 0) using FFDM Mammography and DBT Mammography
- interventionNames
- Device: FFDM Mammography
- Device: DBT Mammography
- label
- Screening Cases
- description
- Collection of cases who underwent routine screening mammography using FFDM Mammography and DBT Mammography
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For Screening Subjects * Be at least 40 years of age, are * Asymptomatic, * Scheduled for a routine screening mammogram For Recall Subjects * Be at least 18 years of age, * Received a BIRADS 0 within the last 60 days * Are recalled for additional imaging For Diagnostic Subjects * Be at least 18 years of age, * Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days. * Understand requirements and willing to participate in study Exclusion Criteria: * Presence of a breast implant. * Women with only a single breast; for example, post mastectomy patients. * Is pregnant or believes she may be pregnant. * A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding. * A woman who has significant existing breast trauma within the last one year. * Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations. * A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year. * Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution. * Is an inmate (see US Code of Federal Regulations 45CFR46.306).
References
Publications (0)
Data not yet available
No reference posted for this study.