Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions

NCT04835246 | Unknown

• 1 other identifier: EFCNX002
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the diagnostic performance of a Raman spectroscopy analysis device - Spectra IMDx for the detection of gastric cancer and precancerous lesions in vivo.

Conditions

Gastric Cancer; Gastric Precancerous Lesion

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Spectra IMDx system

  To assess the sensitivity of Spectra IMDx system for the detection of gastric cancer and precancerous lesions in vivo in the presence of using histological diagnosis as the gold standard. Diagnostic measurements will be assessed in this trial. Using the histopathological diagnosis as the gold standard, true positives (TPs), true negatives (TNs), false positives (FPs) and false negatives (FNs) can be obtained for both Spectra IMDx (IMDx) system. Sensitivity = TP/(TP + FN).

  During the procedure

Secondary Outcomes (2)

• Specificity of Spectra IMDx system

  During the procedure

• Accuracy of Spectra IMDx system

  During the procedure

Study Arms (1)

Spectra IMDx

EXPERIMENTAL

The physician will be asked to give a diagnosis of the lesion under White light endoscopy (WLE) firstly and the endoscopic diagnosis result will be recorded on case report form. Then the physician will introduce the probe of Spectra IMDx system to contact and assess the lesion. The Spectra IMDx system will detect the scattering light signal from the lesion and assess the risk of the lesion being high-grade intraepithelial neoplasia or gastric cancer, and display the result on the Spectra IMDx screen. The Spectra IMDx assessment will be recorded on case report form. Both the patient and doctor will be blinded from the results from Spectra IMDx system. After Spectra IMDx system examination, the physician takes biopsy sample(s) in suspected lesion for further histopathological diagnosis.

Device: Spectra IMDx system

Interventions

Spectra IMDx system DEVICE

The Spectra IMDx system is intended to be used in conjunction with conventional white light endoscopy in upper gastrointestinal endoscopic procedure to identify patients with high risk of developing and/or having gastric cancer and it is intended for use on patients above and equal to the age of 18.

Spectra IMDx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is older than 18 years of age.
• The subject is undergoing upper GI endoscopy for suspected intraepithelial neoplasia or gastric cancer lesions (less than 20mm)
• The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
• The subject must be willing and able to comply with all study procedures.

You may not qualify if:

• The subject has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
• The subject shows presence of active gastrointestinal bleeding or coagulopathy precluding biopsies.
• The subject has rare gastric malignancies such as gastrointestinal stromal tumors (GISTs), lymphomas and neuroendocrine tumors （NETs）.
• The subject is pregnant.
• The subject with liver cirrhosis, impaired renal function, acute gastrointestinal (GI) bleeding, esophageal varices, jaundice, and GI post-surgery
• The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy
• The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study
• The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a five-day washout period before gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
• The subject is unwilling or unable to provide signed informed consent.

Sponsors & Collaborators

• Endofotonics Pte Ltd: lead
• Zhongshan Hospital Xiamen University: collaborator

Study Sites (1)

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hongzhi Xu, MD, PhD

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Wei, MD, PhD

CONTACT

+65 69577585; contact@endofotonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: October 7, 2019
• Primary Completion: May 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Locations

CN (1)