Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non respondants of neo treatment<br>those patients with no response or partial response when administered with Chemotherapy prior to sugery | Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer<br>* Evaluate response to neoadjuvant treatment in advanced breast cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness) | 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). | Baseline and after neoadjuvant treatment (4-6 months) |