At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MRI scan (diagnostic test), Radiologist training (other)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- 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. · Radiologist training — other: Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Imperial College London, looks at people with early-stage rectal cancer or large rectal polyps (small growths in the bowel). It uses MRI (magnetic resonance imaging — a scan that uses magnets and radio waves to make detailed pictures inside the body) before treatment, to see whether major surgery to remove part of the bowel can be avoided.
Who can take part
- Have a rectal tumour, or a suspected tumour, that is at an early stage — either T3b or less on an MRI scan, or pT2 or less after it has been removed, or 20mm or more seen during an examination of the bowel with a camera (endoscopy), with signs it might be cancer
- Are aged 16 or over
Who may not be able to
- Have cancer that has already spread to other parts of the body when first checked
- Have a biopsy-proven rectal cancer that is not an adenocarcinoma (the most common type of bowel cancer)
- Cannot have an MRI scan for medical reasons
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 16 Years to 100 Years
- Who
- All
- Number of participants
- 200
- Started
- 2024-09-01
- Last checked
- 2024-10
Plain English Summary
What is this study?
- • Testing a new treatment for rectal cancer
- • NA - 200 participants
- • 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)
Who can take part?
- • Ages 16 Years to 100 Years
- • Diagnosed with rectal cancer
Where?
- • Reading - Royal Berkshire Hospital
- • Amersham - Buckinghamshire Healthcare Nhs Trust
- • London - University College London Hospitals Nhs Foundation Trust
- • London - King'S College Hospital Nhs Foundation Trust
- • +19 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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%.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or...
- ✓Be aged 16 years or over
Who cannot take part
- ✗Have that has spread disease at time of initial staging
- ✗Have a biopsy-proven rectal cancer which is not adenocarcinoma
- ✗Are not safe to use for MRI
See the full criteria
Where Is This Study? (23 UK sites)
Royal Berkshire Hospital
Reading RG1 5AN, United Kingdom
Buckinghamshire Healthcare Nhs Trust
Amersham AMERSHAM, United Kingdom
University College London Hospitals Nhs Foundation Trust
London NW1 2PG, United Kingdom
King'S College Hospital Nhs Foundation Trust
London SE5 9RS, United Kingdom
West Middlesex Hospital
London SW10 9NH, United Kingdom
Imperial College Healthcare Nhs Trus
London W2 1BL, United Kingdom
The Hillingdon Hospitals Nhs Foundation Trust
Uxbridge UB8 3NN, United Kingdom
Hampshire Hospitals Nhs Foundation Trust
Basingstoke RG24 9NA, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Kent & Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
Maidstone Hospital
Maidstone ME16 9QQ, United Kingdom
Westmorland General Hospital
Kendal LA9 7RG, United Kingdom
Leicester Royal Infirmary
Leicester LE1 5WW, United Kingdom
St George'S Hospital
Tooting SW17 0QT, United Kingdom
John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
Stafford ST16 2LP, United Kingdom
Frimley Health Nhs Foundation Trust
Camberley GU16 7UJ, United Kingdom
St Helier Hospital
Carshalton SM5 1AA, United Kingdom
Kingston Hospital Nhs Foundation Trust
Kingston upon Thames KT2 7QB, United Kingdom
Croydon Health Services Nhs Trust
Thornton Heath CR7 7YE, United Kingdom
Tonna Hospital
Swansea SA11 3LX, United Kingdom
Salisbury District Hospital
Salisbury SP2 8BJ, United Kingdom
St Marks Bowel Cancer Screening Centre
Harrow HA1 3UJ, United Kingdom
How to Get in Touch
Caroline Martin
Sponsor contactCONTACT
Syvella Ellis
Sponsor contactCONTACT