A Study On The Prediction of Neoadjuvant Efficacy For Rectal Cancer Based On MR Cytometry Imaging and Deep-radiomics

• Conditions: Rectal Cancer, Adenocarcinoma

• Registration Number: NCT07107815
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

This study employed MR cytometry imaging combined with deep-radiomic research methods to predict the heterogeneity of rectal cancer, and constructed a model to predict the sensitivity to neoadjuvant therapy and potential mechanisms, assisting clinicians in early identification of high-risk tumors and patients with treatment-susceptible rectal cancer, and selecting individualized treatment plans, thereby improving patient prognosis. To this end, the investigators need to collect the clinical diagnosis and treatment data of patients, surgical and biopsy pathological information, pre-treatment rectal MRI images and colonoscopy biopsy tissue sections, and follow up on the surgical pathological results and recurrence of patients. This study is a non-interventional diagnostic study, which does not interfere with the routine diagnosis and treatment of patients, does not affect any medical rights of patients, and does not increase any medical risks.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-15
• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Newly diagnosed rectal adenocarcinoma without previous treatment
• Complete radical surgery in the institute
• Complete rectal MRI within 2 weeks before surgery

Exclusion Criteria

• Concomitant malignancies or systemic disease
• Inadequate MR image quality for analysis
• Incomplete clinicopathological data
• Loss of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival	From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Pathological complete response	One month after surgery
Pathological tumor regression grade	One month after surgery

Secondary Outcome Measures

Name	Time	Method
Pathological differentiation grade	One month after surgery

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China