Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Enrollment
- 5000
- Locations
- 8
- Primary Endpoint
- Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females ≥ 18 years up to 85 years old
- •Individuals referred to hospitals for diagnosis of breast cancer
- •Availability of radiological images: 2D mammography or 2D synthetic digital tomosynthesis, ultrasound, or magnetic resonance
- •Availability of pathological report (surgical specimen)
- •Availability of (Neoadjuvant) treatment allocation (scheme, duration, benefit)
- •Availability of treatment response
Exclusion Criteria
- •Patient with incomplete or low-quality data (radiological, pathological or clinical)
Outcomes
Primary Outcomes
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
Time Frame: Baseline and after neoadjuvant treatment (4-6 months)
Proportion of patients who have complete response evaluating the target lesion according to Miller/Payne Grading system \[Ogston et al., 2003\]: 1A. Evaluation of target Tumor: G5 as pathological complete response, no tumor left; G4:more than 90% loss of tumor cells; G3: between 30-90% reduction in tumor cells; G2: loss of tumor \<30%; G1: no reduction. 1B: Evaluating the lymph nodes: A: negative; B: lymph nodes with metastasis and without changes by chemotherapy; C: lymph nodes with metastasis with evidence of partial response, D: lymph nodes with changes attributed to response without residual infiltration. 1C: Using images to evaluated radiological response: Size and diameter in millimeters of the target lesion using RM and TC or PET/CT for extension analysis (lymph nodes and metastasis).