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

Sponsor
Instituto de Investigacion Sanitaria La Fe (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05070884
Collaborator
Karolinska Institutet (Other), Medical University of Gdansk (Other), Medical School University of Zagreb (Other), Medical University of Vienna (Other), Hacettepe University Hospital (Other), Alexander Fleming Institute (Other), Ain Shams University (Other)
5,000
Enrollment
30
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

ArmIntervention/Treatment
non respondants of neo treatment

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
Evaluate response to neoadjuvant treatment in advanced breast cancer

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness) [Baseline and after neoadjuvant treatment (4-6 months)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Female
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Instituto de Investigacion Sanitaria La Fe
  • Karolinska Institutet
  • Medical University of Gdansk
  • Medical School University of Zagreb
  • Medical University of Vienna
  • Hacettepe University Hospital
  • Alexander Fleming Institute
  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier:
NCT05070884
Other Study ID Numbers:
  • RADIOVAL
First Posted:
Oct 7, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021