An interventional study of three MR examination in Rectal Neoplasms, sponsored by Sun Ying-Shi. Active, not recruiting at 11 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Sun Ying-Shi · Not applicable, Interventional, and Diagnostic
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.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 1,614 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Sun Ying-Shi is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Also known as: imaging
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
Time frame: 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
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 2 years
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Sun Ying-Shi