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Enrolling by Invitation

NCT Number: NCT07107815

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pathological complete response

    Time frame: One month after surgery

  2. Pathological tumor regression grade

    Time frame: One month after surgery

  3. progression-free survival

    Time frame: 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

    Time frame: One month after surgery

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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