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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Evaluate response to neoadjuvant treatment in advanced breast cancer
Alexander Fleming
Buenos Aires, Argentina
NOT_YET_RECRUITINGMedical University of Vienna
Vienna, Austria
NOT_YET_RECRUITINGUniversity of Zagreb School of Medicine
Zagreb, Croatia
NOT_YET_RECRUITINGAin Shams University
Cairo, Egypt
NOT_YET_RECRUITINGMedical University of Gdansk
Gdansk, Poland
NOT_YET_RECRUITINGHospital Universitario y Politécnico La Fe de Valencia
Valencia, Spain
RECRUITINGKarolinska Institute
Stockholm, Sweden
NOT_YET_RECRUITINGHacettepe University
Ankara, Turkey (Türkiye)
NOT_YET_RECRUITINGPercentage 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).
Time frame: Baseline and after neoadjuvant treatment (4-6 months)
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