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NCT04103372Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
5 Sept 2019
Start date
1 Sept 2024
Primary completion date
31 Dec 2026
Lead sponsor
Imperial College London
NCT number
NCT04103372

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 1 Sept 2024 to the primary completion date, 31 Dec 2026
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Are contraindicated for MRI

Who 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 20mm or more on endoscopy with suspicion of malignancy
  • Be aged 16 years or over

Age in the registry: 16 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Buckinghamshire Healthcare Nhs Trust
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AmershamUnited KingdomRecruiting
Hampshire Hospitals Nhs Foundation Trust
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BasingstokeUnited KingdomNot yet recruiting
Frimley Health Nhs Foundation Trust
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CamberleyUnited KingdomNot yet recruiting
Kent & Canterbury Hospital
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CanterburyUnited KingdomNot yet recruiting
St Helier Hospital
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CarshaltonUnited KingdomNot yet recruiting
St Marks Bowel Cancer Screening Centre
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HarrowUnited KingdomNot yet recruiting
Westmorland General Hospital
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KendalUnited KingdomNot yet recruiting
Kingston Hospital Nhs Foundation Trust
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Kingston upon ThamesUnited KingdomNot yet recruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomNot yet recruiting
Imperial College Healthcare Nhs Trus
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LondonUnited KingdomNot yet recruiting
University College London Hospitals NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
King's College Hospital NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
West Middlesex Hospital
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LondonUnited KingdomNot yet recruiting
Maidstone Hospital
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MaidstoneUnited KingdomNot yet recruiting
John Radcliffe Hospital
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OxfordUnited KingdomNot yet recruiting
Royal Berkshire Hospital
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ReadingUnited KingdomNot yet recruiting
Salisbury District Hospital
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SalisburyUnited KingdomNot yet recruiting
Southampton General Hospital
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SouthamptonUnited KingdomNot yet recruiting
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
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StaffordUnited KingdomNot yet recruiting
Tonna Hospital
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SwanseaUnited KingdomNot yet recruiting
Croydon Health Services Nhs Trust
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Thornton HeathUnited KingdomNot yet recruiting
St George'S Hospital
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TootingUnited KingdomNot yet recruiting
The Hillingdon Hospitals Nhs Foundation Trust
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UxbridgeUnited KingdomNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.