Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Study Overview
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Brief Summary
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The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

Detailed Description
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We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.

Official Title
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Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Device: three MR examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years T3/4 or node positive biopsy-proved primary rectal cancer Suitable for pre-operative chemoradiotherapy and surgical resection No contraindication to MRI Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: History or concurrent of other cancer Previous therapy to pelvis Unable/unwilling to have MRI Pacemaker or implanted defibrillator Pregnancy, lactation or inadequate contraception Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study Unwilling or unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assessing response with MRI<br>Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration). Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy. All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy. | Device: three MR examination<br>* Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.<br>* Other names: imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery | A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR | 2 years | 
| Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR | A scoring system for predicting pCR will be developed based on MRI parameters | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG) | A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder. | 2 years | 
| Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy | This will be assessed in terms of whether MR imaging at 7-9 weeks after preoperative radio-chemotherapy adds any additional predictive value to imaging performed 14-16 days after initiation of preoperative radio-chemotherapy. | 2 years | 
| MRI-predicted pCR and MRI-predicted response on long-term disease control and survival | 3 years disease-free survival and overall survival will be assessed | 3 years | 
| Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pathological response according to Tumour Regression Grade (TRG) | A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder. | 2 years |