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

NCT07107815 | Enrolling By Invitation

• 1 other identifier: NCC2025C-250
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer, Adenocarcinoma

Keywords

rectal cancer; MR cytometry imaging; deep-radiomics; neoadjuvant therapy

Outcome Measures

Primary Outcomes (3)

• Pathological complete response

  One month after surgery

• Pathological tumor regression grade

  One month after surgery

• 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

Secondary Outcomes (1)

• Pathological differentiation grade

  One month after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese patients diagnosed with rectal cancer through pathological examination

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

• Zhao Q, Shi D, Zhong H, Jin C, Wang Z, Shi Z, Li L, Wang B, Jiang Y, Feiweier T, Xu J, Guo H, Zhang H. The predictive value of MR cytometry in histological differentiation of rectal cancer: an exploratory study. Eur Radiol. 2026 Jan 30. doi: 10.1007/s00330-026-12341-w. Online ahead of print.

  PMID: 41617831 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

CN (1)