Clinical trial · Interventional
Using AI to Select Women for Supplemental MRI in Breast Cancer Screening
Image Analysis With Artificial Intelligence to Increase Precision in Breast Cancer Screening - the ScreenTrust MRI Substudy: a Prospective Trial of AI to Select Women for Supplemental Screening MRI
NCT04832594CI-TRIAL-00070228ScreenTrustMRIunknownN/AClinicalTrials.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 is a prospective clinical trial aiming to determine the ability of an AI pipeline to identify women who would benefit from supplemental MRI in terms of decreasing the number of cancers having a significantly delayed detection
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 |
|---|---|---|---|
| AI selection for supplemental breast MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supplemental MRI
- description
- Women randomized to MRI will be examined using a shortened MRI protocol on a Signa Premier 3T MRI scanner. The MRI examination will be reviewed by two radiologists and assigned BI-RADS score. Appropriate clinical work-up will follow according to the BI-RADS score. BI-RADS 3 or higher at initial MRI will be recalled for a second look ultrasound.
- interventionNames
- Other: AI selection for supplemental breast MRI
- type
- NO_INTERVENTION
- label
- No MRI (standard-of-care)
- description
- Standard-of-care. Both arms will have had a regular screening mammography examination prior to randomization. The "No MRI" arm will have no further intervention.
Primary outcomes (1)
- measure
- Significantly Delayed Breast Cancer Detection per 1000 women
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Complete four-view screening mammography examination Exclusion Criteria: * Women in surveillance program referred from the hereditary cancer unit * Breast implants * Prior breast cancer * Breast feeding * MRI contraindication requiring radiologist assessment * AI Tool unable to process mammograms due to technical reason
References
Publications (1)
- DERIVEDSalim M, Liu Y, Sorkhei M, Ntoula D, Foukakis T, Fredriksson I, Wang Y, Eklund M, Azizpour H, Smith K, Strand F. AI-based selection of individuals for supplemental MRI in population-based breast cancer screening: the randomized ScreenTrustMRI trial. Nat Med. 2024 Sep;30(9):2623-2630. doi: 10.1038/s41591-024-03093-5. Epub 2024 Jul 8. PMID 38977914