Breast Cancer Clinical Trial
— RADIOVALOfficial title:
Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
NCT number | NCT05070884 |
Other study ID # | RADIOVAL |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2023 |
Est. completion date | December 2025 |
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 2025 |
Est. primary completion date | August 2025 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Argentina | Alexander Fleming | Buenos Aires | |
Austria | Medical University of Vienna | Vienna | |
Croatia | University of Zagreb School of Medicine | Zagreb | |
Egypt | Ain Shams University | El Cairo | |
Poland | Medical University of Gdansk | Gdansk | |
Spain | Hospital Universitario y Politécnico La Fe de Valencia | Valencia | |
Sweden | Karolinska Institute | Stockholm | |
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigacion Sanitaria La Fe | Ain Shams University, Alexander Fleming Institute, Hacettepe University Hospital, Karolinska Institutet, Medical School University of Zagreb, Medical University of Gdansk, Medical University of Vienna |
Argentina, Austria, Croatia, Egypt, Poland, Spain, Sweden, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) |
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