Clinical trial · Observational
Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting
Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting - A Retrospective Study (AI-BRACE)
- 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)
Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results. It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic. It is therefore important to test the performance of these systems in this alternative context. This study will use retrospective data, from where it is possible to determine ground truth outcomes with greater confidence, accessing relatively large volumes of data with less patient burden when compared to prospective studies. This important cohort of patients has been less investigated to date, mainly because symptomatic data is typically more difficult to curate than screening data where key data is methodically prospectively collected. The proposed work will be carried out in collaboration with a selected AI vendor and local clinical teams to define optimal use case scenarios for the symptomatic breast clinic.
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 |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mammography Images | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symptomatic breast clinic.
- description
- Patients 18 years or older attending symptomatic breast clinic from January 2015 to December 2019.
- interventionNames
- Procedure: Mammography Images
Primary outcomes (1)
- measure
- Performance of screening tool on symptomatic data, in terms of sensitivity and specificity.
- timeFrame
- 18 months
Secondary outcomes (1)
- measure
- Subgroup analysis based on ground-truth - Normal; Benign; Malignant.
- timeFrame
- 18 months
- description
- This is either normal, benign or malignant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Patients 18 years or older attending symptomatic breast clinic. * Mammography images, including both full field two-dimensional digital mammography and digital breast tomosynthesis. * Dates of attendance will be from January 2015\* to December 2019 at the lead data collection site. Dates of collection may be different at the other sites depending on local data curation consideration but will be a minimum of 2 years prior to study start to allow determination of ground truth. * If any mammography images prior to 2015 should be available at the lead site, these will be collected as well (a maximum of 3). Prior mammograms will also be collected at the other sites if available, depending on local PACS set-up. Exclusion criteria * Patients under the age of 18 years. * Patients on the National data opt out.
References
Publications (0)
Data not yet available