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

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Sun Yat-sen University

Status

Enrolling

Conditions

Rectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05523245
2021ZSLYEC-478

Details and patient eligibility

About

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.

Enrollment

1,700 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,700 participants in 2 patient groups

complete response
Description:
Patients receiving neoadjuvant therapy achieved pathological complete response before LARC.
non complete response
Description:
Patients receiving neoadjuvant therapy did not achieve pathological complete response before LARC.

Trial contacts and locations

4

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Central trial contact

Xiaochun Meng; Peiyi Xie

Data sourced from clinicaltrials.gov

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