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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Buckinghamshire Healthcare Nhs Trust
RECRUITING
Amersham
Hampshire Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Basingstoke
Frimley Health Nhs Foundation Trust
NOT_YET_RECRUITING
Camberley
Kent & Canterbury Hospital
NOT_YET_RECRUITING
Canterbury
St Helier Hospital
NOT_YET_RECRUITING
Carshalton
St Marks Bowel Cancer Screening Centre
NOT_YET_RECRUITING
Harrow
Westmorland General Hospital
NOT_YET_RECRUITING
Kendal
Kingston Hospital Nhs Foundation Trust
NOT_YET_RECRUITING
Kingston Upon Thames
Leicester Royal Infirmary
NOT_YET_RECRUITING
Leicester
Imperial College Healthcare Nhs Trus
NOT_YET_RECRUITING
London
King'S College Hospital Nhs Foundation Trust
NOT_YET_RECRUITING
London
University College London Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
London
West Middlesex Hospital
NOT_YET_RECRUITING
London
Maidstone Hospital
NOT_YET_RECRUITING
Maidstone
John Radcliffe Hospital
NOT_YET_RECRUITING
Oxford
Royal Berkshire Hospital
NOT_YET_RECRUITING
Reading
Salisbury District Hospital
NOT_YET_RECRUITING
Salisbury
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
NOT_YET_RECRUITING
Stafford
Tonna Hospital
NOT_YET_RECRUITING
Swansea
Croydon Health Services Nhs Trust
NOT_YET_RECRUITING
Thornton Heath
St George'S Hospital
NOT_YET_RECRUITING
Tooting
The Hillingdon Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Uxbridge
Contact Information
Primary
Caroline Martin
c.martin1@imperial.ac.uk
+44 (0) 7749 655 817
Backup
Syvella Ellis
giclinicaltrials@imperial.ac.uk
+44 (0) 7732 315 234
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 200
Treatments
No_intervention: Control Arm Schedule
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.
Experimental: Intervention Arm Schedule
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.
Authors
Gina Brown
Related Therapeutic Areas
Sponsors
Collaborators: RM Partners West London Cancer Alliance, Pelican Cancer Foundation
Leads: Imperial College London

This content was sourced from clinicaltrials.gov

Similar Clinical Trials