Prospective Intestinal Ultrasound Study for Artificial Intelligence Algorithm Development

Inflammatory bowel disease, including Crohn disease and ulcerative colitis, requires reliable assessment of intestinal inflammation to support clinical monitoring and treatment decisions. Intestinal ultrasound is a non-invasive, point-of-care imaging method that can assess bowel inflammation without radiation exposure. However, its interpretation may vary by operator experience and local scanning practice.

This prospective, multicentre, observational study will collect de-identified intestinal ultrasound images, cine loops, and limited associated metadata from adults aged 18 years and older. Eligible participants may be healthy individuals with no known inflammatory bowel disease or individuals undergoing intestinal ultrasound for inflammatory bowel disease screening, monitoring, or another clinical reason. Intestinal ultrasound examinations will be performed as part of routine clinical care. The study does not add a treatment intervention, investigational drug, experimental device, or clinically directed diagnostic procedure.

Following informed consent, ultrasound images and cine loops generated during the routine examination will be exported in de-identified DICOM format. Limited information relevant to artificial intelligence development and validation, such as age, sex, self-reported race, pregnancy status, eligibility confirmation, and relevant scan-related or pre-existing clinical information, may also be recorded. Direct personal identifiers and personal health information will be removed before the data are transferred outside the clinical site.

The de-identified data will be reviewed for appropriate de-identification and formatting before secure transfer to Dova Health Intelligence Inc. The data will be annotated and used to develop, train, tune, and test computer vision algorithms designed to identify bowel structures and measure bowel wall thickness on intestinal ultrasound. The study will also assess the feasibility of developing algorithms to evaluate bowel wall layer stratification, luminal diameter, bowel wall flow, bowel wall scarring, gastrointestinal motility, and mesenteric fat proliferation.

The primary objective is to evaluate whether the computer vision algorithm prototype can measure bowel wall thickness with performance comparable to manual measurements by experienced sonographers. Secondary objectives include evaluating the quality, diversity, and usability of the collected ultrasound data for artificial intelligence development and assessing the feasibility of measuring additional intestinal ultrasound features.

The algorithms developed in this study are investigational and will not be used in routine clinical care during the study. No participant-level algorithm findings will be returned to participants, and participation is not expected to provide a direct clinical benefit. The primary foreseeable risk is a loss of confidentiality; this risk is mitigated through de-identification at the study site, verification of de-identification before transfer, secure file transfer, controlled access, and secure cloud-based storage. The study plans to enroll up to 95 participants internationally, including up to 30 participants at the British Columbia site.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Individuals who have recently taken contrast-enhancing compounds.