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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05070884
Recruitment Status : Not yet recruiting
First Posted : October 7, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborators:
Karolinska Institutet
Medical University of Gdansk
Medical School University of Zagreb
Medical University of Vienna
Hacettepe University Hospital
Alexander Fleming Institute
Ain Shams University
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Study Description
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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 disease Intervention/treatment
Breast Cancer Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with chemotherapy prior to surgery
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05070884


Contacts
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Contact: Ana Penades-Blasco, M.Ec +34 961245633 ana_penades@iislafe.es

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
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT05070884    
Other Study ID Numbers: RADIOVAL
First Posted: October 7, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/D

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases