Post-Neoadjuvant Treatment MRI Based AI System to Predict pCR for Rectal Cancer

NCT04278274 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 205

Last updated 2022-10-26

No results posted yet for this study

Summary

In this study, investigators seek for a better way to identify the potential pathologic complete response (pCR) patients form non-pCR patients with locally advanced rectal cancer (LARC), based on their post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data.

Previously, a post neoadjuvant treatment MRI based radiomics AI model had been constructed and trained. Here, the predictive power of this artificial intelligence system and expert radiologist to identify pCR patients from non-pCR LARC patients will be compared in this prospective, multicenter, back-to-back clinical study

Conditions

Interventions

PROCEDURE

artificial intelligence prediction system

The tumor ROI in the post- neoadjuvant treatment MRI images will be manually delineated, and further subjected to the AI prediction system arm to verify the predictive accuracy of this AI prediction system in identifying the pCR individuals from non-pCR patients with LARC.

PROCEDURE

the radiologists

The enrolled patients will be assigned to the trained experienced radiologists to evaluate their predictive accuracy in identifying the pCR individuals from non-pCR patients

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    collaborator OTHER
  • The Third Affiliated Hospital of Kunming Medical College.

    collaborator OTHER
  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xiangbo Wan, MD, PhD · Sixth Affiliated Hospital, Sun Yat-sen University

  • Weidong Han, MD, PhD · Sir Run Run Shaw Hospital

  • Zhenhui Li, MD · The Third Affiliated Hospital of Kunming Medical College.

Eligibility

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

Timeline & Regulatory

Start
2020-02-08
Primary Completion
2022-12-10
Completion
2023-03-31

Countries

  • China

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 NCT04278274 on ClinicalTrials.gov