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Validation of an Artificial Intelligence System Based on Raman Spectroscopy for Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04869618
Recruitment Status : Recruiting
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Information provided by (Responsible Party):
Changi General Hospital

Brief Summary:
Early detection and treatment of gastric premalignant lesion and early gastric cancer (EGC) have been proposed to improve outcomes of gastric cancer. Gastric dysplasia is a premalignant lesion and the penultimate stage in gastric carcinogenesis. On white light endoscopy (WLE), it is difficult to distinguish gastric dysplasia and EGC from benign pathology such as gastric intestinal metaplasia (GIM). Image enhanced endoscopy such as narrow-band imaging (NBI) is recommended to improve characterization of suspicious gastric lesions detected on WLE. Magnified-endoscopy with NBI (ME-NBI) have been shown to be superior to HD-WLE for diagnosis of GIM and EGC. Data on gastric dysplasia is less robust. Ultimately, biopsy is required to confirm diagnosis of gastric dysplasia/EGC. Gastric dysplasia can be classified into low-grade dysplasia (LGD) or high-grade dysplasia (HGD). Biopsy sampling may not be representative of the final histopathological grade of resected specimens and may under-stage dysplasia. Thus, endoscopic resection (ER) is recommended for gastric dysplasia and EGC on biopsy for diagnostic and therapeutic purpose. The current gap is to improve concordance of endoscopic and histologic findings of gastric dysplasia and early gastric cancer. Raman spectroscopy based artificial intelligence system (SPECTRA IMDx) was developed to provide an objective method to identify patients with gastric premalignant lesions and EGC. SPECTRA IMDx interrogate tissues at the cellular level and utilizes molecular information to provide actionable information to endoscopist during gastroscopy. Studies on diagnostic performance using Raman spectroscopy analysis devices have shown high sensitivity and specificity in detection of gastric cancer and precancerous lesions compared to WLE. However, these studies included few GIM, gastric dysplasia and gastric carcinoma. It is still unclear if Raman spectroscopy outperforms WLE in diagnosis of gastric HGD and EGC. In addition, the Raman spectroscopy algorithm is only able to characterize lesions into high risk (HGD/EGC) versus low risk (GIM/LGD/Gastritis/Normal). It is also uncertain if this technology is able to differentiate GIM and LGD. We plan to conduct a prospective trial to validate the diagnostic accuracy of SPECTRA for prediction of gastric HGD and EGC prior to gastric ER. Hypothesis: SPECTRA IMDx is able to differentiate higher risk lesions (HGD/EGC) from lower risk tissue/lesion (GIM/LGD/Gastritis/Normal)

Condition or disease Intervention/treatment Phase
Gastric Dysplasia Gastric Intestinal Metaplasia Gastric Cancer Device: Raman spectroscopy based device (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: Validation of an Artificial Intelligence System Based on Raman Spectroscopy (SPECTRA IMDx) for Real Time Diagnosis of Gastric Premalignant Lesions and Early Gastric Cancer in Patients Undergoing Gastric Endoscopic Resection
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Intervention Details:
  • Device: Raman spectroscopy based device (SPECTRA IMDx)
    The SPECTRA IMDx system is developed on the basis of Raman spectroscopy. It comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The SPECTRA IMDx system also comprises a SPECTRA IMDx probe that can be 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, which is then parsed through an analysis algorithm for diagnosis.

Primary Outcome Measures :
  1. Diagnostic performance of SPECTRA IMDx for assessment of lower risk lesion (GIM/LGD/Gastritis/Normal) and higher risk lesions (HGD/EGC) against the gold standard of histopathology from gastric resection specimen [ Time Frame: 24 months ]
    Diagnostic performance: accuracy, positive predictive value and negative predictive value

Secondary Outcome Measures :
  1. Comparison of diagnostic performance of SPECTRA IMDx versus HD-WLE for assessment of high grade dysplasia/early gastric cancer [ Time Frame: 24 months ]
  2. Feasibility of Raman spectroscopy to differentiate GIM, LGD, HGD and EGC against the gold standard of histopathology [ Time Frame: 24 months ]
    sensitivity, specificity and accuracy

  3. Feasibility of Raman spectroscopy to identify gastric dysplasia and EGC from scar tissues post-ER during surveillance endoscopy. [ Time Frame: 24 months ]
  4. Evaluation of performance of HD-WLE combined with NBI in detection of HGD/EGD prior to ER. [ Time Frame: 24 months ]
    sensitivity, specificity and accuracy

Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. Known diagnosis of gastric dysplasia with visible lesion or early gastric cancer amenable to gastric ER (EMR or ESD); diagnosis made based on biopsy from gastroscopy performed within past six months
  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. Subjects without mental capacity, refusal to provide consent, incarcerated status, pregnant subjects.
  2. Subjects with advanced gastric cancer not amenable to endoscopic resection
  3. Subjects with bleeding disorders, such as haemophilia, in whom ER and biopsies are contraindicated.
  4. Subjects with active bleeding or coagulopathy precluding ER and biopsies.
  5. Subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF) and advanced liver cirrhosis.
  6. Subjects on regular anti-platelet medications except aspirin or anti-coagulants must be able to undergo adequate washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.

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 identifier (NCT number): NCT04869618

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Contact: Chin Kimg Tan, MD 6788 8833

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Changi General Hospital Recruiting
Singapore, Singapore, 529889
Contact: Chin Kimg Tan, MD    +65-6788 8833   
Sub-Investigator: Tiing Leong Ang         
Sub-Investigator: James Wei Quan Li         
Sub-Investigator: Andrew Boon Eu Kwek         
Sub-Investigator: Lai Mun Wang         
Sponsors and Collaborators
Changi General Hospital
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Principal Investigator: Chin Kimg Tan, MD Changi General Hospital
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Responsible Party: Changi General Hospital Identifier: NCT04869618    
Other Study ID Numbers: 2021/2105
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 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
Additional relevant MeSH terms:
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Stomach Neoplasms
Precancerous Conditions
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pathologic Processes