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

Last updated: October 30, 2024
Sponsor: Imperial College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colorectal Cancer

Digestive System Neoplasms

Treatment

MRI scan

Radiologist training

Clinical Study ID

NCT04103372
DOCUMAS 24HH8769
  • Ages 16-100
  • All Genders

Study Summary

When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery.

We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure.

In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage orpT2 or less after excision, or 20mm or more on endoscopy with suspicion ofmalignancy

  2. Be aged 16 years or over

Exclusion

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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: MRI scan
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
December 31, 2031

Study Description

Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. <10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report.

Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to >50%.

Connect with a study center

  • Royal Berkshire Hospital

    Reading, Berkshire RG1 5AN
    United Kingdom

    Site Not Available

  • Buckinghamshire Healthcare Nhs Trust

    Amersham, Buckinghamshire AMERSHAM
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare Nhs Trus

    London, Greater London W2 1BL
    United Kingdom

    Site Not Available

  • King'S College Hospital Nhs Foundation Trust

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • University College London Hospitals Nhs Foundation Trust

    London, Greater London NW1 2PG
    United Kingdom

    Site Not Available

  • West Middlesex Hospital

    London, Greater London SW10 9NH
    United Kingdom

    Site Not Available

  • The Hillingdon Hospitals Nhs Foundation Trust

    Uxbridge, Greater London UB8 3NN
    United Kingdom

    Site Not Available

  • Hampshire Hospitals Nhs Foundation Trust

    Basingstoke, Hampshire RG24 9NA
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Kent & Canterbury Hospital

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Maidstone Hospital

    Maidstone, Kent ME16 9QQ
    United Kingdom

    Site Not Available

  • Westmorland General Hospital

    Kendal, Lancashire LA9 7RG
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • The Royal Marsden NHSHFT

    Chelsea, London SW3 6JJ
    United Kingdom

    Site Not Available

  • St George'S Hospital

    Tooting, London SW17 0QT
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Site Not Available

  • Nhs Staffordshire and Stoke-on-Trent Integrated Care Board

    Stafford, Staffordshire ST16 2LP
    United Kingdom

    Site Not Available

  • Frimley Health Nhs Foundation Trust

    Camberley, Surrey GU16 7UJ
    United Kingdom

    Site Not Available

  • St Helier Hospital

    Carshalton, Surrey SM5 1AA
    United Kingdom

    Site Not Available

  • Kingston Hospital Nhs Foundation Trust

    Kingston Upon Thames, Surrey KT2 7QB
    United Kingdom

    Site Not Available

  • Croydon Health Services Nhs Trust

    Thornton Heath, Surrey CR7 7YE
    United Kingdom

    Site Not Available

  • Tonna Hospital

    Swansea, Wales SA11 3LX
    United Kingdom

    Site Not Available

  • Salisbury District Hospital

    Salisbury, Wiltshire SP2 8BJ
    United Kingdom

    Site Not Available

  • St Marks Bowel Cancer Screening Centre

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

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