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NCT Number: NCT04103372

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

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.

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Key information

Conditions

Rectal Cancer Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Berkshire Hospital, Reading, Berkshire, United Kingdom

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About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Radiologist training

Other

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

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.

    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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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'

  9. 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'

  10. 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'

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Pelican Cancer Foundation
  • RM Partners West London Cancer Alliance

Registry information

Acronym: PRESERVE

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Sep 25, 2019
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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