Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI

NCT ID: NCT05523245

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-24

Study Completion Date

2027-12-31

Brief Summary

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Establish a deep learning model based on multi-parameter magnetic resonance imaging to predict the efficacy of neoadjuvant therapy for locally advanced rectal cancer.This study intends to combine DCE with conventional MRI images for DL, establish a multi-parameter MRI model for predicting the efficacy of CRT, and compare it with the DL and non-artificial quantitative MRI diagnostic model constructed by conventional MRI to evaluate the role of DL in MRI predicting CRT. And this study also tries to build a DL platform to assess the efficacy of LARC neoadjuvant radiotherapy and chemotherapy, accurately assess patients' complete respose (pCR) after CRT, and provide an important basis for guiding clinical decision-making.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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complete response

Patients receiving neoadjuvant therapy achieved pathological complete response before LARC.

No interventions assigned to this group

non complete response

Patients receiving neoadjuvant therapy did not achieve pathological complete response before LARC.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical suspicion or colonoscopic pathology of rectal cancer
* Age over 18 years
* Informed consent and signed informed consent form

Exclusion Criteria

* Poor magnetic resonance image quality, such as severe artifacts
* Previous treatment for rectal cancer
* History or combination of other malignant tumours
* Not Locally Advanced Rectal Cancer (LARC)
* Not received neoadjuvant therapy or not completed neoadjuvant therapy
* No surgery
* Time interval between MRI and surgery was more than 2 weeks
* Patients were lost to follow-up and voluntarily withdrew from the study due to adverse reactions or other reasons
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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xiaochun meng

The Director of Diagnostic Radiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Fifth Affiliated Hospital, Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Xiaochun Meng

Role: CONTACT

13719166488

Peiyi Xie

Role: CONTACT

13724071514

Facility Contacts

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Xiaochun Meng

Role: primary

13719166488

Other Identifiers

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2021ZSLYEC-478

Identifier Type: -

Identifier Source: org_study_id

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