Improving MRI accuracy for early-stage rectal cancer treatment
Official title: Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
Run by Imperial College London · NCT04103372 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 100 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Imperial College London Academic / other |
| Locations | 23 sites (Reading, Berkshire and 22 other locations) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2031 |
| Registry record updated | November 4, 2024 |
| Trial ID | NCT04103372 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with metastatic disease, non-adenocarcinoma rectal malignancies, or contraindications for MRI will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with similar MRI assessment approaches, indicating potential for this method to improve patient outcomes.
Who can join: the full rules
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 it's running
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Buckinghamshire Healthcare Nhs Trust
Amersham, Buckinghamshire, United Kingdom Recruiting -
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom Not yet recruiting -
University College London Hospitals Nhs Foundation Trust
London, Greater London, United Kingdom Not yet recruiting -
King'S College Hospital Nhs Foundation Trust
London, Greater London, United Kingdom Not yet recruiting -
West Middlesex Hospital
London, Greater London, United Kingdom Not yet recruiting -
Imperial College Healthcare Nhs Trus
London, Greater London, United Kingdom Not yet recruiting
Show 17 more locations
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The Hillingdon Hospitals Nhs Foundation Trust
Uxbridge, Greater London, United Kingdom Not yet recruiting -
Hampshire Hospitals Nhs Foundation Trust
Basingstoke, Hampshire, United Kingdom Not yet recruiting -
Southampton General Hospital
Southampton, Hampshire, United Kingdom Not yet recruiting -
Kent & Canterbury Hospital
Canterbury, Kent, United Kingdom Not yet recruiting -
Maidstone Hospital
Maidstone, Kent, United Kingdom Not yet recruiting -
Westmorland General Hospital
Kendal, Lancashire, United Kingdom Not yet recruiting -
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom Not yet recruiting -
St George'S Hospital
Tooting, London, United Kingdom Not yet recruiting -
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom Not yet recruiting -
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
Stafford, Staffordshire, United Kingdom Not yet recruiting -
Frimley Health Nhs Foundation Trust
Camberley, Surrey, United Kingdom Not yet recruiting -
St Helier Hospital
Carshalton, Surrey, United Kingdom Not yet recruiting -
Kingston Hospital Nhs Foundation Trust
Kingston upon Thames, Surrey, United Kingdom Not yet recruiting -
Croydon Health Services Nhs Trust
Thornton Heath, Surrey, United Kingdom Not yet recruiting -
Tonna Hospital
Swansea, Wales, United Kingdom Not yet recruiting -
Salisbury District Hospital
Salisbury, Wiltshire, United Kingdom Not yet recruiting -
St Marks Bowel Cancer Screening Centre
Harrow, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Gina Brown, MD — Imperial College London
- Study coordinator: Caroline Martin
- Email: c.martin1@imperial.ac.uk
- Phone: +44 (0) 7749 655 817
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.