NCT04278274

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

A Post-Neoadjuvant Treatment MRI Based AI System to Predict Pathologic Complete Response for Patients With Rectal Cancer: A Multicenter, Prospective Clinical Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 205 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III stage will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. All participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (TME) surgery. Patients with LARC who received neoadjuvant treatment will be enrolled and their post-neoadjuvant treatment MRI images will be used to predict their pathologic response (pCR vs. non-pCR). The artificial intelligence prediction system and the expert radiologist will define the pathologic response as pCR or non-pCR, respectively. The pathologist will provide the final pathology report of TME surgery specimen (pCR or non-pCR) as a standard. The predictive efficacy of these two back-to-back approaches generated will be compared in this multicenter, prospective clinical study.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-08
• Primary completion: 2022-12-10
• Completion: 2023-03-31
• First posted: 2020-02-20
• Last updated: 2022-10-26

Locations

3 sites across 1 country: China