NCT03706664Fut, nem toboroz
Small Bowel Deep Learning Algorithm Project
Pilot Study to Develop a Deep Learning Algorithm for Identification & Scoring of Terminal Ileal Crohn's Disease in Magnetic Resonance Enterography Images.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 18.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 226 (tervezett)
- Első benyújtás
- 2018. okt. 11.
- Kezdés
- 2019. márc. 1.
- Elsődleges befejezés
- 2028. aug.
- Fő szponzor
- London North West Healthcare NHS Trust
- Betegségek
- Crohn-betegség
- NCT-szám
- NCT03706664
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 226
- 2019. márc. 1. és az elsődleges befejezés (2028. aug.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patient has undergone previous small or large bowel resection (this will distort anatomy and is beyond the scope of the present project). Patients' with other previous surgeries are eligible.
Más betegség
- Patients with large bowel Crohn's disease not continuous with the terminal ileum.
Egyéb
- Poor quality MRI images as judged by consensus Radiologist opinion.
- No more than 3 MRI scans will come from the same patient.
- MR Enterography shows any bowel abnormality not due to Crohn's.
Kiket keres a vizsgálat
- Patient's age \>16 years of age, (this age cut off has been used in the recent METRIC trial investigating imaging in Crohn's disease)
- MRI sequences obtained include axial T2 weighted images; coronal T2 weighted images and axial post contrast MRI images.
- Normal MR Enterography studies reviewed in consensus by two Radiologists (UP \& PL). Normal is defined as no sites of small or large bowel Crohn's disease.
- MR Enterography studies reviewed in consensus by two Radiologists shows terminal ileal Crohn's disease. Patients with more than one segment of small bowel Crohn's disease including terminal ileum are eligible. Patients with terminal ileal Crohn's disease continuous with large bowel are eligible.
- Diagnosis of Crohn's disease of terminal ileum based on endoscopic, histological and radiological findings. (This criteria has been used in the recent METRIC trial investigating imaging in Crohn's disease).
Életkor a regiszterben: 16 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| St Mark's Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | London | Egyesült Királyság | Ismeretlen állapot |
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