N/A
Completed N=3,521
Multicenter Hologic Tomosynthesis Study
Source: ClinicalTrials.gov NCT00971087 ↗Enrolled (actual)
3,521
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: 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. — 0.907; 0.867 Proportion — p=0.009
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.907; 0.867 | 0.009 sig |
| SECONDARY Analysis of ROC Performance in Subjects With Dense Breasts |
0.893; 0.848 | 0.045 sig |
| SECONDARY Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM |
54.6; 67.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00971087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.