Clinical trial · Observational
Collection of FUJIFILM's 3Dimensional Mammograms
Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
NCT01542814CI-TRIAL-000124583DMcompletedClinicalTrials.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 image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
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 |
|---|---|---|---|
| 2D FFDM | Device | — | UNRESOLVED |
| 3Dimensional Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Fujifilm 3Dimensional Mammography
- description
- Group of subjects being given Fujifilm 3D Mammography Imaging
- interventionNames
- Device: 2D FFDM
- label
- 2D FFDM
- description
- Group of Subjects receiving FujiFilm or other FDA Approved 2D Mammography Imaging
- interventionNames
- Device: 3Dimensional Mammography
Primary outcomes (1)
- measure
- Acquire screening cases with and without breast cancer.
- timeFrame
- 18-months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female. * Any ethnic or racial origin. * Must come through the study via the screening or diagnostic pathway described above. * Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. * Meet none of the exclusion criteria. 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. * Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations. * A woman who has had a mammogram performed for the purpose of therapy portal planning. * Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts. * Cannot, for any known reason, undergo follow-up mammography 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.