Clinical trial · Observational
Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer
Multi-reader, Multi-case, Observer-blind, Retrospective, Pivotal Study to Evaluate Effectiveness of Investigational Device in the Assistance of Detection and Diagnosis of Breast Cancer During Screening Mammography Interpretation
NCT05615298CI-TRIAL-00062147completedClinicalTrials.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 study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
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 |
|---|---|---|---|
| Mammography | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer
- description
- * Negative image data: Has been interpreted as negative in screening mammograms * Benign image data: Has a suspicious lesion for breast cancer in screening mammograms but confirmed as a benign through the follow-up biopsy or has been interpreted as a benign in screening mammograms and confirmed as a benign in the further diagnostic images taken after at least two years from the screening mammograms.
- interventionNames
- Radiation: Mammography
- label
- Non-cancer
- description
- Has a suspicious lesion for breast cancer in screening mammograms and confirmed as a cancer (malignant) through the follow-up biopsy.
- interventionNames
- Radiation: Mammography
Primary outcomes (1)
- measure
- Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Female * Any ethnic origin * Acquired with devices from two manufacturers: Hologic and GE * 4 views (RMLO, LMLO, RCC, LCC) images of FFDM (Full-Field Digital mammography) Exclusion Criteria: * Previous core needle biopsy in breast for past 2 years * Previous vacuum-assisted biopsy, surgical biopsy or surgery in breast * Previous breast cancer * Lactating when taking screening mammograms * Presence of a breast implant in screening mammograms * Presence of a pacemaker in screening mammograms * Inadequate quality status such as insufficient anatomical coverage of screening mammograms
References
Publications (0)
Data not yet available
No reference posted for this study.