This observational study will use intestinal ultrasound images to help develop computer programs that may make it easier to assess bowel inflammation.
The study will include adults who are healthy or who are having an intestinal ultrasound as part of care for inflammatory bowel disease, such as Crohn disease or ulcerative colitis. Researchers want to find out whether a computer program can measure bowel wall thickness from ultrasound images as accurately as experienced ultrasound clinicians. They will also explore whether the program can identify other changes in the bowel.
Participants will have an intestinal ultrasound as part of their usual care. People who agree to take part will allow the research team to use de-identified ultrasound images and a small amount of related health information. No medication, experimental treatment, or additional ultrasound procedure will be given for this study. The computer program will not be used to make decisions about a participant's care, and participants will not receive individual results from the program.
Adults aged 18 years or older.
Individuals who are either healthy with no known finding of inflammatory bowel disease before the ultrasound examination or undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason.
Individuals who are able and willing to provide informed consent for the collection and use of de-identified study data.
Individuals who do not meet the study demographic requirements.
Individuals unable or unwilling to provide informed consent.
Pregnant individuals.
Individuals with health conditions managed using drugs or medical-device intervention, or with unmanaged conditions or conditions requiring monitoring, that could affect study eligibility or the ultrasound assessment.
The study population will consist of adults aged 18 years and older who are either healthy or undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason. Participants will be recruited through the IBD Centre of BC and other participating study sites. The study may include individuals with inflammatory bowel disease and healthy volunteers. The study aims to include a diverse participant population to support evaluation of artificial intelligence algorithm performance across different participant characteristics.
Cohort
Prospective
De-identified Intestinal Ultrasound Data Collection
Other interventionIntestinal ultrasound images and cine loops will be collected from adults undergoing ultrasound as part of routine clinical care. Following informed consent, the images and cine loops will be de-identified and used for artificial intelligence algorithm development, training, tuning, and testing. The study does not assign participants to receive an intervention, and the ultrasound is not performed solely for research purposes. The artificial intelligence algorithms developed using the data will not be used to guide participant care or provide individual diagnostic results during the study.
Artificial Intelligence-Generated Bowel Wall Thickness Measurement Agreement
Agreement between bowel wall thickness measurements generated by the artificial intelligence computer-vision algorithm and manual bowel wall thickness measurements performed by experienced sonographers using de-identified intestinal ultrasound images and cine loops. Agreement will be assessed using the pre-specified performance metric in the statistical analysis plan.
Bowel Wall Layer Stratification Feasibility
Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall layer stratification.
Luminal Diameter Measurement Feasibility
Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable luminal diameter measurement.
Bowel Wall Flow Assessment Feasibility
Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall flow assessment.
Bowel Wall Scarring Assessment Feasibility
Proportion of de-identified intestinal ultrasound images and cine loops for which the artificial intelligence algorithm generates an interpretable bowel wall scarring assessment.
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University of British Columbia
Lead sponsor
IBD Centre of BC
Collaborator
Providence Health Care Ventures
Collaborator
Dova Health Intelligence Inc
Collaborator
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