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

NCT04103372 | Recruiting DMC

• 1 other identifier: DOCUMAS 24HH8769
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

Rectal Cancer; Colo-rectal Cancer

Keywords

early stage; early phase; Endoscopic Mucosal Resection; Endoscopic Submucosal Dissection; Histopathological Staging; MDT Decision Making; MRI Staging; Quality of Life; Radiotherapy; Rectal preservation; Shared decision making; Significant Rectal Polyps; Transanal Endoscopic Microsurgery; Transanal Minimally Invasive Surgery

Outcome Measures

Primary Outcomes (1)

• Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.

  Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention.

  1 year

Secondary Outcomes (18)

• Proportion of patients with technically adequacate scans before and after intervention

  1 year

• Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention

  1 year

• Proportion of MRI reports with T substage given before and after intervention

  1 year

• Number of patients identified on imaging as suitable for rectal preservation by local excision

  1 year

• Number of patients identified by MDT as suitable for rectal preservation by local excision

  1 year

Study Arms (2)

Control Arm Schedule

NO INTERVENTION

All sites will begin in the Control arm, with patients recruited to the Control Arm Schedule. Clinical investigations prior to treatment, during treatment, after surgery and during further treatment should be performed as per standard clinical practice and as clinically indicated. Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point.

Intervention Arm Schedule

EXPERIMENTAL

Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . The transition period lasts one month during which recruitment is halted and two interventions implemented: 1. MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy. 2. Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer. Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point.

Diagnostic Test: MRI scan; Other: Radiologist training

Interventions

MRI scan DIAGNOSTIC_TEST

MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.

Intervention Arm Schedule

Radiologist training OTHER

Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.

Intervention Arm Schedule

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Be aged 16 years or over

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• Pelican Cancer Foundation: collaborator
• RM Partners West London Cancer Alliance: collaborator

Study Sites (23)

Royal Berkshire Hospital

Reading, Berkshire, RG1 5AN, United Kingdom

NOT YET RECRUITING

Buckinghamshire Healthcare Nhs Trust

Amersham, Buckinghamshire, AMERSHAM, United Kingdom

RECRUITING

University College London Hospitals Nhs Foundation Trust

London, Greater London, NW1 2PG, United Kingdom

NOT YET RECRUITING

King'S College Hospital Nhs Foundation Trust

London, Greater London, SE5 9RS, United Kingdom

NOT YET RECRUITING

West Middlesex Hospital

London, Greater London, SW10 9NH, United Kingdom

NOT YET RECRUITING

Imperial College Healthcare Nhs Trus

London, Greater London, W2 1BL, United Kingdom

NOT YET RECRUITING

The Hillingdon Hospitals Nhs Foundation Trust

Uxbridge, Greater London, UB8 3NN, United Kingdom

NOT YET RECRUITING

Hampshire Hospitals Nhs Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

NOT YET RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

NOT YET RECRUITING

Kent & Canterbury Hospital

Canterbury, KENT, CT1 3NG, United Kingdom

NOT YET RECRUITING

Maidstone Hospital

Maidstone, KENT, ME16 9QQ, United Kingdom

NOT YET RECRUITING

Westmorland General Hospital

Kendal, Lancashire, LA9 7RG, United Kingdom

NOT YET RECRUITING

Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

NOT YET RECRUITING

St George'S Hospital

Tooting, London, SW17 0QT, United Kingdom

NOT YET RECRUITING

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

NOT YET RECRUITING

Nhs Staffordshire and Stoke-on-Trent Integrated Care Board

Stafford, Staffordshire, ST16 2LP, United Kingdom

NOT YET RECRUITING

Frimley Health Nhs Foundation Trust

Camberley, Surrey, GU16 7UJ, United Kingdom

NOT YET RECRUITING

St Helier Hospital

Carshalton, Surrey, SM5 1AA, United Kingdom

NOT YET RECRUITING

Kingston Hospital Nhs Foundation Trust

Kingston upon Thames, Surrey, KT2 7QB, United Kingdom

NOT YET RECRUITING

Croydon Health Services Nhs Trust

Thornton Heath, Surrey, CR7 7YE, United Kingdom

NOT YET RECRUITING

Tonna Hospital

Swansea, Wales, SA11 3LX, United Kingdom

NOT YET RECRUITING

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

NOT YET RECRUITING

St Marks Bowel Cancer Screening Centre

Harrow, HA1 3UJ, United Kingdom

NOT YET RECRUITING

Related Publications (2)

• Detering R, van Oostendorp SE, Meyer VM, van Dieren S, Bos ACRK, Dekker JWT, Reerink O, van Waesberghe JHTM, Marijnen CAM, Moons LMG, Beets-Tan RGH, Hompes R, van Westreenen HL, Tanis PJ, Tuynman JB; Dutch ColoRectal Audit Group*. MRI cT1-2 rectal cancer staging accuracy: a population-based study. Br J Surg. 2020 Sep;107(10):1372-1382. doi: 10.1002/bjs.11590. Epub 2020 Apr 16.

  PMID: 32297326 BACKGROUND

• Balyasnikova S, Read J, Wotherspoon A, Rasheed S, Tekkis P, Tait D, Cunningham D, Brown G. Diagnostic accuracy of high-resolution MRI as a method to predict potentially safe endoscopic and surgical planes in patients with early rectal cancer. BMJ Open Gastroenterol. 2017 Aug 14;4(1):e000151. doi: 10.1136/bmjgast-2017-000151. eCollection 2017.

  PMID: 29259791 BACKGROUND

Related Links

• National Bowel Cancer Audit. Annual Report 2022 \[Internet\]. Leeds: NBOCA; 2022

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Neoplasms

Interventions

Magnetic Resonance Imaging

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; Colonic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gina Brown, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Martin

CONTACT

+44 (0) 7749 655 817; c.martin1@imperial.ac.uk

Syvella Ellis

CONTACT

+44 (0) 7732 315 234; giclinicaltrials@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, stepped-wedge cluster randomised trial. This pilot study will run for 9 months and utilise a stepped wedge cluster randomised controlled trial design (including transition period). Sites will enter data from the diagnostic and treatment pathways of all rectal cancer patients who are eligible for primary surgical treatment, eg those radiologically staged as less than or equal to T3b or with confirmed as less than or equal to pT2N0 pathological staging. Prior to the trial opening the participating sites will be randomly allocated a number, which will determine the number of months the site will remain in the control and then subsequently the intervention phase of the trial.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 25, 2019
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (23)