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

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Breast Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT05070884

RADIOVAL

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

5,000 participants in 1 patient group

non respondants of neo treatment

Description:

those patients with no response or partial response when administered with Chemotherapy prior to sugery

Treatment:

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