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Improving MRI accuracy for early-stage rectal cancer treatment

Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery

Not applicable Interventional Imperial College London · NCT04103372

This study tests a new way for doctors to read MRIs to see if it can help more people with early-stage rectal cancer avoid major surgery and keep their bowel function.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages16 Years to 100 Years
SexAll
SponsorImperial College London Academic / other
Locations23 sites (Reading, Berkshire and 22 other locations)
Trial IDNCT04103372 on ClinicalTrials.gov

What this trial studies

This project aims to enhance the accuracy of MRI assessments for early-stage rectal cancer and significant rectal polyps, thereby reducing the need for major surgical interventions. By training radiologists in a new MRI reading method called PRESERVE, the study seeks to increase the identification rate of early rectal cancers from 30% to 89%. The goal is to enable more patients to undergo local excision procedures that preserve bowel function and quality of life, rather than facing unnecessary major surgeries. The study involves collaboration with multiple healthcare institutions to implement this improved staging system.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 16 and over with a rectal tumor staged as T3b or lower on MRI or with a suspected malignancy.

Not a fit: Patients with metastatic disease, non-adenocarcinoma rectal malignancies, or contraindications for MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the number of patients undergoing major surgeries for rectal cancer, improving their quality of life.

How similar studies have performed: Other studies have shown success with similar MRI assessment approaches, indicating potential for this method to improve patient outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or 20mm or more on endoscopy with suspicion of malignancy
2. Be aged 16 years or over

Exclusion Criteria:

1. Have metastatic disease at time of initial staging
2. Have a biopsy-proven rectal malignancy which is not adenocarcinoma
3. Are contraindicated for MRI

Where this trial is running

Reading, Berkshire and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Rectal CancerColo-rectal Cancerearly stageearly phaseEndoscopic Mucosal ResectionEndoscopic Submucosal DissectionHistopathological StagingMDT Decision Making
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.