NCT04103372 Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
| NCT ID | NCT04103372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Gina Brown, MD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT04103372 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 100 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04103372 currently recruiting?
Yes, NCT04103372 is actively recruiting participants. Contact the research team at c.martin1@imperial.ac.uk for enrollment information.
Where is the NCT04103372 trial being conducted?
This trial is being conducted at Reading, United Kingdom, Amersham, United Kingdom, London, United Kingdom, London, United Kingdom and 11 additional locations.
Who is sponsoring the NCT04103372 clinical trial?
NCT04103372 is sponsored by Imperial College London. The principal investigator is Gina Brown, MD at Imperial College London. The trial plans to enroll 200 participants.
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