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

Breast Cancer Clinical Trial

— RADIOVAL  

Official title:

Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05070884
• Other study ID #: RADIOVAL
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Ana Penades-Blasco, M.Ec
• Phone: +34 961245633
• Email: ana_penades[@]iislafe.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• 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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer
Evaluate response to neoadjuvant treatment in advanced breast cancer

Locations

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

Sponsors (8)

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

Countries where clinical trial is conducted

Argentina,  Austria,  Croatia,  Egypt,  Poland,  Spain,  Sweden,  Turkey, 

Outcome

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)