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Artificial Intelligence System Based on Raman Spectroscopy in Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT04888299
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Device: Raman spectroscopy (SPECTRA IMDx) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Intervention Details:
  • Device: Raman spectroscopy (SPECTRA IMDx)
    The SPECTRA IMDx comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The SPECTRA IMDx probe is connected with the main system. The SPECTRA IMDx probe is an assembly of optical fibres and optical components arranged for maximal transmission of light energy. When in use, the laser system will emit a 785nm near infra-red laser that will be transmitted through the SPECTRA IMDx probe to the distal end. When the laser is interrogated upon a tissue surface, the light energy is absorbed and reflected. The reflected energy is then collected from the distal end of the SPECTRA IMDx probe, transmitted back to the main system, and passed through the spectrometer. The collected signal is then processed to obtain the clean Raman signal for diagnostic classification.


Primary Outcome Measures :
  1. Feasibility of Raman spectroscopy to identify mucosal healing in IBD and IBD-related dysplasia against the gold standard of histopathology [ Time Frame: 24 months ]
    sensitivity, specificity


Secondary Outcome Measures :
  1. Diagnostic performance of Raman spectroscopy for assessment of mmucosal healing in IBD and IBD-related dysplasia against the gold standard of histopathology [ Time Frame: 24 months ]
    positive predictive value and negative predictive value



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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04888299


Contacts
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Contact: Tiing Leong Ang +65-6788 8833 ang.tiing.leong@singhealth.com.sg

Locations
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Singapore
Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Tiing Leong Ang, MBBS    +65-67888833    ang.tiing.leong@singhealth.com.sg   
Sub-Investigator: James Wei Quan Li         
Sub-Investigator: Andrew Boon Eu Kwek         
Sub-Investigator: Chin Kimg Tan         
Sub-Investigator: Lai Mun Wang         
Sponsors and Collaborators
Changi General Hospital
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Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT04888299    
Other Study ID Numbers: 2021/2000
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changi General Hospital:
inflammatory bowel disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis