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

Primary Purpose

Gastric Cancer, Gastric Precancerous Lesion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spectra IMDx system
Sponsored by
Endofotonics Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Zhongshan Hospital Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spectra IMDx

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Specificity of Spectra IMDx system
To assess the specificity and accuracy 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. Specificity = TN/(TN + FP).
Accuracy of Spectra IMDx system
To assess the accuracy 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. Accuracy = (TP + TN)/(TP + TN + FP + FN).

Full Information

First Posted
March 31, 2021
Last Updated
April 12, 2021
Sponsor
Endofotonics Pte Ltd
Collaborators
Zhongshan Hospital Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT04835246
Brief Title
Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions
Official Title
A Prospective, Single Centre Study Evaluating The Diagnostic Performance of Spectra IMDx System for The Detection of Gastric Cancer and Precancerous Lesions In Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endofotonics Pte Ltd
Collaborators
Zhongshan Hospital Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, single centre study to assess the diagnostic performance of Spectra IMDx system in detection of gastric cancer and precancerous lesions in subjects with suspected gastric intraepithelial neoplasia who are undergoing upper gastrointestinal endoscopic procedures. The Spectra IMDx system comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The Spectra IMDx system also comprises a Raman probe that can be connected with the main system. The Raman 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 Raman 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 Raman 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 the analysis algorithm to evaluate its risk for cancer (high/low). Feedback will then be generated on the GUI in real time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Precancerous Lesion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
185 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spectra IMDx
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spectra IMDx system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of Spectra IMDx system
Description
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).
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Specificity of Spectra IMDx system
Description
To assess the specificity and accuracy 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. Specificity = TN/(TN + FP).
Time Frame
During the procedure
Title
Accuracy of Spectra IMDx system
Description
To assess the accuracy 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. Accuracy = (TP + TN)/(TP + TN + FP + FN).
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wei, MD, PhD
Phone
+65 69577585
Email
contact@endofotonics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhi Xu, MD, PhD
Organizational Affiliation
Zhongshan Hospital Xiamen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongzhi Xu, MD, PhD
Phone
+86 0592 2186786
Email
xuhongzhi@xmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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