Clinical trial · Observational
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
NCT00759447CI-TRIAL-00037225completedClinicalTrials.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)
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
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 |
|---|---|---|---|
| Genesis and Gemini | Device | — | UNRESOLVED |
| Investigational 3D Mammography system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3D investigational imaging
- description
- Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition
- interventionNames
- Device: Investigational 3D Mammography system
- label
- 3D Imaging with commercial Mammography Device
- interventionNames
- Device: Genesis and Gemini
Primary outcomes (1)
- measure
- Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
- timeFrame
- 1 year
- description
- images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Female, any ethnic origin * No contraindication for diagnostic mammography Exclusion Criteria: * Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants. * Under 30 years of age at the time of consent * Unable to understand and execute written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.