A Clinical Evaluation of AI Solutions Developed in the CHAIMELEON Project for Cancer: Prostate, Lung, Breast, Colon and Rectum

NCT06950996 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-04-30

No results posted yet for this study

Summary

The goal of this observational study is to see how useful an experimental viewer and AI solutions are for clinicians in their daily work. The investigators want to find out if the AI helps clinicians interpret medical images for different types of cancer.

The AI solutions aim to:

* Classify whether prostate cancer is low or high risk
* Classify the histological subtype in breast cancer
* Estimate the life expectancy of patients with lung cancer
* Determine the size of colon cancer, lymph node involvement and the possibility of metastasis..
* Assess the invasion of sorrounding tissues in the case of rectum cancer. The study will involve clinicians from various centres who will review a set of cases not previously analysed by the AI. Clinicians will do this in two phases: first using only their own expertise and then with the help of the AI solutions.

The technical team want to see if the AI solutions assist clinicians and could become useful in the everyday clinical practice. Clinicians will complete a survey to share their feedback on the usability of the platform and how helpful the AI solutions are.

Conditions

Interventions

OTHER

Risk in prostate cancer

the prediction involves the classification of the prostate cancer according to the level of prostatic antigen (PSA), the biopsy classification of the aggressiveness of the tumour, and also the localisation of the tumour

OTHER

Life expectancy in lung cancer

Clinicians will evaluate life expectancy in lung cancer using CTs, together with some clinical information.

OTHER

Histological subtype

An assessment by pathology of the subtype of breast tumour

OTHER

Staging of colon cancer

classify size, lymph node involvement and possibility of metastasis in medical images (computerized tomosynthesis) of thorax and pelvis region

OTHER

invasion in rectum cancer

assess whether vascular extramural o mesorectal fascia has been invaded in the tumour using magnetic resonance medical images taken at diagnosis in the pelvic region

Sponsors & Collaborators

  • University of Pisa

    collaborator OTHER
  • University Hospital Rijeka

    collaborator OTHER
  • University of Messina

    collaborator OTHER
  • Istanbul Medipol University Hospital

    collaborator OTHER
  • Centro Hospitalar do Porto

    collaborator OTHER
  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER
  • IRCCS Policlinico S. Donato

    collaborator OTHER
  • National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

    collaborator OTHER
  • Charite University, Berlin, Germany

    collaborator OTHER
  • Osakidetza

    collaborator OTHER
  • Le Collège des Enseignants de Radiologie de France

    collaborator OTHER
  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2024-10-30
Completion
2024-11-01

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950996 on ClinicalTrials.gov