Clinical trial · Observational
Exploring the Potential of Artificial Intelligence for Earlier Breast Cancer Detection: A Retrospective Multi-Reader Study Based on AI-Assisted Mammographic Interpretation (EARLIEST-AI)
- 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)
EARLIEST-AI Study type: Two-phase, multi-reader, blinded retrospective observational study based on data from a single clinic. The primary objective of the study is to assess the sensitivity and specificity of radiologists and Artificial Intelligence (AI) in interpreting mammographic examinations for breast cancer detection in a scenario where no previous examinations are available, and to compare the diagnostic performance of radiologists with and without AI support. The secondary objectives of the study are to assess the independent diagnostic performance of Computer Aided Detection (CAD) software, including sensitivity and specificity in identifying histopathologically confirmed breast cancer cases; to assess inter-reader and intra-reader variability in interpretation with and without AI support; to assess the agreement between AI outputs and histopathological findings; and to assess the impact of mammogram technical parameters on AI performance. Time frame: Review of a subset of mammograms randomly selected from those performed between January 1, 2012 and December 31, 2024. Imaging findings were classified according to the Breast Imaging Reporting and Data System (BI-RADS). Inclusion criteria: 1. Female patients aged 30 years or older. 2. One or more mammograms performed between January 1, 2012 and December 31, 2024. 3. Meets one of the following criteria: 3.1 Histopathologically confirmed diagnosis of breast cancer within 6 months of mammogram, 3.2 or two consecutive mammograms with BI-RADS 1 or BI-RADS 2. Exclusion criteria: 1. Mammograms of poor quality or artifacts that do not allow for reliable assessment. 2. History of breast surgery or previous breast cancer treatment that has significantly altered breast morphology. 3. Data deficiencies, including: 3.1. lack of previous histopathological data 3.2. or lack of available follow-up data.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AI (Artificial Intelligence) | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early Detection of Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- BI-RADS 1-2 patients
- label
- BI-RADS 6 patients
Primary outcomes (5)
- measure
- Standalone reader sensitivity
- timeFrame
- through study completion, an average of 1 year
- measure
- Standalone CAD sensitivity
- timeFrame
- through study completion, an average of 1 year
- measure
- Augmented Reader sensitivity
- timeFrame
- through study completion, an average of 1 year
- measure
- Standalone reader detection to diagnostic time (MAE)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * . Exclusion Criteria: * .
References
Publications (0)
Data not yet available