A Feasibility Study of an Artificial Intelligence System Based on Raman Spectroscopy for In-vivo Assessment of Mucosal Healing and Diagnosis of Colorectal Neoplasia in Adults With Inflammatory Bowel Disease
Trial ID: NCT04888299
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-04-14
Completion date: 2023-04
Sponsor: Changi General Hospital
Conditions: Inflammatory Bowel Diseases
Interventions: Raman spectroscopy (SPECTRA IMDx)
Locations: Changi General Hospital
Countries: Singapore
Enrollment: 100
Age range: 21 Years - 90 Years
Sex: ALL

Summary:
Inflammatory bowel diseases (IBD) are chronic inflammatory disorders that can be categorized as ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis (IC). Deep remission has been shown to improve disease outcome. There may be a lack of concordance between endoscopic and histologic remission. IBD patients with long standing colitis are at risk of developing dysplasia and colorectal cancer (CRC). However, it can be challenging to diagnose dysplasia in IBD patients during colonoscopy, as dysplasia frequently manifests as non-pedunculated lesions that present with only subtle visible changes or are even invisible due to the surrounding inflammation, scarring, pseudopolyps, or hyperplasia. Although white light endoscopy and chromoendoscopy are the current standard modality of imaging, there is still a gap to be bridged, in terms of improving endoscopic diagnosis of dysplasia and improving concordance of endoscopic and histologic remission. Raman spectroscopy is an inelastic light scattering technique provide specific fingerprints of molecular compositions and structures of biological tissues. It may be able to provide additional diagnostic information over standard endoscopy. A second-generation Raman endoscope system for improving in vivo tissue characterization and diagnosis during colonoscopy has been developed (SPECTRA IMDx system). Preliminary data suggested its utility in the diagnosis of colorectal neoplasia during colonoscopy. There is currently a lack of data concerning the application of this novel technology in the context of IBD. Specifically, whether the spectral signals generated can be used to better classify disease remission, and thus achieve higher concordance with histology when compared to standard endoscopy. It is also unclear whether this technology can be used to differentiate dysplastic mucosa from non-dysplastic mucosal in IBD patients.

Hypotheses

1. Raman spectroscopy based artificial intelligence system has the potential to be used to differentiate disease remission from active mucosal inflammation and hence improve concordance between endoscopic and histologic remission, with the potential to decrease the need for random biopsies real-time during colonoscopy.
2. Raman spectroscopy based artificial intelligence system has the potential to differentiate dysplastic mucosa in IBD patients (low grade and high grade dysplasia; colorectal cancer) from non-dysplastic mucosa. real-time during colonoscopy.

Eligibility criteria:
Inclusion Criteria:

1. Known or suspected diagnosis of ulcerative colitis or Crohn's disease
2. Age 21 to 90 years (selected age range based on demographic of patients managed at Changi General Hospital)
3. Ability to provide informed consent

Exclusion Criteria:

1. Presence of significant coagulopathy that precludes endoscopic biopsies
2. Refusal to provide consent
3. Pregnant subjects
4. Incarcerated status

Outcomes:
Feasibility of Raman spectroscopy to identify mucosal healing in IBD and IBD-related dysplasia against the gold standard of histopathology