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

February 1, 2023 updated by: Instituto de Investigacion Sanitaria La Fe

Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Not yet recruiting
        • Alexander Fleming
        • Principal Investigator:
          • Daniel Cl Mysler
  • Austria
      • Vienna, Austria
        • Not yet recruiting
        • Medical University of Vienna
        • Principal Investigator:
          • Pascal Baltzer
  • Croatia
      • Zagreb, Croatia
        • Not yet recruiting
        • University of Zagreb School of Medicine
        • Principal Investigator:
          • Boris Brkljacic
  • Egypt
      • El Cairo, Egypt
        • Not yet recruiting
        • Ain Shams University
        • Principal Investigator:
          • Abeer Hamed
  • Poland
      • Gdańsk, Poland
        • Not yet recruiting
        • Medical University of Gdansk
        • Principal Investigator:
          • Maciej Bobowicz, MD, PhD
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe de Valencia
        • Contact:
        • Principal Investigator:
          • Luis Marti-Bonmati, MD, PhD
        • Sub-Investigator:
          • Ana Santaballa, MD, PhD
        • Sub-Investigator:
          • Guillermina Montoliu, MD, PhD
        • Sub-Investigator:
          • Rosa García, MD
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska Institute
        • Principal Investigator:
          • Fredrik Strand
        • Sub-Investigator:
          • Apostolia Tsirikoglou, PhD
  • Turkey
      • Ankara, Turkey
        • Not yet recruiting
        • Hacettepe University
        • Principal Investigator:
          • Meltem Gulsun Akpinar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients treated with chemotherapy prior to surgery

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
Time Frame: 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).
Baseline and after neoadjuvant treatment (4-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Collaborators

Karolinska Institutet
Medical University of Vienna
Ain Shams University
Medical University of Gdansk
Medical School University of Zagreb
Hacettepe University Hospital
Alexander Fleming Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2023

Primary Completion (ANTICIPATED)

August 1, 2025

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (ACTUAL)

October 7, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADIOVAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

N/D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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