Clinical Trial

Small Bowel Deep Learning Algorithm Project

Active, Not Recruiting
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Summary
Crohn's disease affects 200,000 people in the UK (\~1 in 500), most are young (diagnosed \< 35 years) with costs of direct medical care exceeding £500 million. Crohn's disease is caused by an auto-immune response and affects any part of the digestive tract, most commonly the last segment of the small bowel (the terminal ileum). Magnetic resonance imaging (MRI) plays a role in 3 areas: Crohn's disease diagnosis , monitoring treatment response \& assessing development of complications. To evaluate the small bowel using MRI, Radiologists visually examine the scan slice-by-slice. The interpretation is time consuming and error-prone because of disease presentation variability and differentiation of diseased segments from collapsed segments. Deep learning for image analysis is based on a computer algorithm "learning" from human (Radiologist) generated training data. This method has been successfully applied to medical imaging, for example computer detection of lung cancer on chest X-rays. This pilot study investigates if a deep learning algorithm can identify and score segments of inflamed terminal ileum affected by Crohn's disease. To our knowledge this is the first project attempting to develop such an algorithm.The study will retrospectively review MR images obtained as part of standard care from patients being investigated for, Crohn's or being followed up with Crohn's disease. 226 patients' images will be used for the study. On fully anonymised images two Radiologists working at Northwick Park Hospital will score and outline normal and abnormal loops of terminal ileum. Imperial College computer science department will then develop a deep learning algorithm from imaging features of normal and abnormal loops. The study end-point is algorithm performance vs. images labelled by Radiologists. The eventual aim is to develop an algorithm that assists Radiologists in the accurate diagnosis and follow-up of patients with Crohn's disease.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2018-10-11; most recent amendment 2026-05-14.
Status change: Recruiting → Active, Not Recruiting 2020-02-26
Status change: Not Yet Recruiting → Recruiting 2019-08-20
Trial Details
NCT Number NCT03706664
Lead Sponsor London North West Healthcare NHS Trust
Collaborators: Imperial College London
Conditions Crohn Disease
Enrollment 226 participants
Start Date 2019-03-01
Primary Completion 2028-08 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-18