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

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical suspicion or colonoscopic pathology of rectal cancer

Age over 18 years

Informed consent and signed informed consent form

Disqualifiers

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)

Trial population

Patients with locally advanced rectal cancer (LARC) treated with neoadjuvant therapy and radical surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,700 Participants
are grouped into 2 trial groups
Group A: complete response
Group B: non complete response

Trial outcomes

Primary outcomes

1

The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of models in prediction tumor response

The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of models in identifying the pCR candidates from non-pCR individuals among neoadjuvant therapy treated LARC patients will be calculated.

Time frame
baseline and pre-operation

Secondary outcomes

1

The specificity of models in prediction tumor response

The sensitivity of models in identifying the pCR candidates from non-pCR individuals among neoadjuvant therapy treated LARC patients will be calculated.

Time frame
baseline and pre-operation
2

The sensitivity of models in prediction tumor response

The sensitivity of models in identifying the pCR candidates from non-pCR individuals among neoadjuvant therapy treated LARC patients will be calculated.

Time frame
baseline and pre-operation
3

The positive predictive value of models in prediction tumor response

The positive predictive value of models in identifying the pCR candidates from non-pCR individuals among neoadjuvant therapy treated LARC patients will be calculated.

Time frame
baseline and pre-operation
4

The negative predictive value of models in prediction tumor response

The negative predictive value of models in identifying the pCR candidates from non-pCR individuals among neoadjuvant therapy treated LARC patients will be calculated.

Time frame
baseline and pre-operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sixth Affiliated Hospital, Sun Yat-sen University

Lead sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

First Affiliated Hospital of Jinan University

Collaborator