Clinical trial · Interventional
Multicenter Hologic Tomosynthesis Study
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
- 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)
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hologic Selenia Dimensions Digital Breast Tomosynthesis System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Subjects undergoing breast cancer screening
- description
- The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy
- interventionNames
- Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System
Primary outcomes (1)
- measure
- To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
- timeFrame
- At time of exam
- description
- ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
Secondary outcomes (2)
- measure
- Analysis of ROC Performance in Subjects With Dense Breasts
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Any ethnic origin * No contraindication of routine bilateral mammography Exclusion Criteria: * Any contraindications to mammographic screening, including but not limited to: * Significant existing breast trauma * Pregnancy * Lactating * Previous surgical biopsy * Previous breast cancer * Placement of an internal breast marker * Breast implants * Unable to understand and execute written informed consent * Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
References
Publications (0)
Data not yet available