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

October 30, 2024 updated by: Imperial College London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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%.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Harrow, United Kingdom, HA1 3UJ
        • Not yet recruiting
        • St Marks Bowel Cancer Screening Centre
        • Contact:
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
    • Buckinghamshire
      • Amersham, Buckinghamshire, United Kingdom, AMERSHAM
        • Recruiting
        • Buckinghamshire Healthcare NHS Trust
        • Contact:
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Not yet recruiting
        • King's College Hospital NHS Foundation Trust
        • Contact:
      • London, Greater London, United Kingdom, NW1 2PG
        • Not yet recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Contact:
      • London, Greater London, United Kingdom, SW10 9NH
      • London, Greater London, United Kingdom, W2 1BL
        • Not yet recruiting
        • Imperial College Healthcare Nhs Trus
        • Contact:
      • Uxbridge, Greater London, United Kingdom, UB8 3NN
        • Not yet recruiting
        • The Hillingdon Hospitals NHS Foundation Trust
        • Contact:
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
      • Southampton, Hampshire, United Kingdom, SO16 6YD
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Not yet recruiting
        • Kent & Canterbury Hospital
        • Contact:
      • Maidstone, Kent, United Kingdom, ME16 9QQ
    • Lancashire
      • Kendal, Lancashire, United Kingdom, LA9 7RG
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
    • London
      • Tooting, London, United Kingdom, SW17 0QT
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
    • Staffordshire
      • Stafford, Staffordshire, United Kingdom, ST16 2LP
        • Not yet recruiting
        • Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
        • Contact:
    • Surrey
      • Camberley, Surrey, United Kingdom, GU16 7UJ
        • Not yet recruiting
        • Frimley Health NHS Foundation Trust
        • Contact:
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • Not yet recruiting
        • St Helier Hospital
        • Contact:
      • Kingston Upon Thames, Surrey, United Kingdom, KT2 7QB
      • Thornton Heath, Surrey, United Kingdom, CR7 7YE
        • Not yet recruiting
        • Croydon Health Services NHS Trust
        • Contact:
    • Wales
      • Swansea, Wales, United Kingdom, SA11 3LX
    • Wiltshire
      • Salisbury, Wiltshire, United Kingdom, SP2 8BJ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: MRI scan
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.
Other: Radiologist training
Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with technically adequacate scans before and after intervention
Time Frame: 1 year
Proportion of patients scanned with high resolution MR in the correct planes
1 year
Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention
Time Frame: 1 year
Proportion of reports where primary tumour has been characterised by morphology before and after intervention in i) endoscopy, ii) radiology reports before and after intervention
1 year
Proportion of MRI reports with T substage given before and after intervention
Time Frame: 1 year
Proportion of reports where T substage of primary tumour has been recorded before and after intervention
1 year
Number of patients identified on imaging as suitable for rectal preservation by local excision
Time Frame: 1 year
Proportion of imaging reports where suitable patients are identified on the report as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
1 year
Number of patients identified by MDT as suitable for rectal preservation by local excision
Time Frame: 1 year
Proportion of MDT decisions where patients suitable for rectal preservation by local excision are identified and comparison of treatments offered to patients by the MDT, before and after the intervention
1 year
Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist
Time Frame: 1 year
Proportion of patients with >1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with >1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME that have <1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
1 year
Numebr of patients with R0 by local excision or TME as appropriate
Time Frame: 1 year
Proportion of patients with R0 that have >1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with R0 that have>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME with R0 that have <1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
1 year
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time Frame: 1 year, 3 years, 5 years
Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
1 year, 3 years, 5 years
Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time Frame: 1 year, 3 years, 5 years
Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
1 year, 3 years, 5 years
Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time Frame: 1 year, 3 years, 5 years
Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
1 year, 3 years, 5 years
Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time Frame: 1 year, 3 years, 5 years
Comparison of self evaluation of overall health and quality of life scores before and after intervention. Answers are rated from 1 very poor to 7 excellent
1 year, 3 years, 5 years
Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery
Time Frame: 1 year
Comparison of total costs of hospital procedures performed based on individual pathways before and after intervention
1 year
Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery
Time Frame: 1 year
Comparison of cost of inpatient episodes based on individual pathways before and after intervention
1 year
Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery
Time Frame: 1 year
Comparison of total cost of outpatient episodes based on individual pathways before and after intervention
1 year
Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery
Time Frame: 1 year
Comparison of total cost of treatments delivered in the community based on individual pathways before and after intervention
1 year
Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery
Time Frame: 1 year, 3 years, 5 years
DFS and stoma free survival in patients based on individual pathways before and after intervention
1 year, 3 years, 5 years
Assessment results for the effectiveness of mrSRT after a year from training
Time Frame: 1 year
Determine longevity of training by assessment of radiologists trained with the PRESERVE mrSRT accuracy 1 year after training
1 year
Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer
Time Frame: 2 months, 1 year, 3 years, 5 years
Comparison of relative % histopathological biomarkers screening panels between patients identified on imaging as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
2 months, 1 year, 3 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation
RM Partners West London Cancer Alliance

Investigators

  • Principal Investigator: Gina Brown, MD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCUMAS 24HH8769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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