Condition category
Digestive System
Date applied
17/06/2015
Date assigned
23/06/2015
Last edited
23/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Conventional diagnostic and screening tools such as white-light endoscopy have significant limitations for examining upper gastrointestinal (GI) tract lesions due to their poor diagnostic sensitivity. Therefore, there is an urgent need for the development of a new endoscopic imaging technique to complement white-light endoscopy for non-invasive diagnosis of such lesions. A novel NIR autofluorescence spectroscopy and imaging system associated with Raman spectroscopy allow a larger sample of body tissue to be probed beyond the tissue surface. This has the added benefit of minimizing concerns regarding tissue damage during examinations. Through this study, the clinical significance of this research can be a new diagnostic tool that may have significant potential for the non-invasive diagnosis of upper GI lesions. It may also serve as a tool for guiding and directing biopsies for histopathological investigations, reducing the number of negative biopsies, increasing the number of diagnoses, and reducing the medical costs for the patients.

Who can participate?
Adult patients undergoing endoscopy for suspected or known GI lesions.

What does the study involve?
The patients are first given a mild sedative as used in routine gastroscopic examinations. The upper GI tract is carefully inspected under white light endoscopy. White light endoscopic findings based on tissue morphology are documented. Observation of the mucosa (inner lining of the GI tract) morphology are classified as normal mucosa, nonspecific inflammatory mucosa or abnormal mucosa. If any tissues are suspected abnormal by the endoscopist in charge, NIR excitation light is shined on the suspicious tissue sites indicated by the white light endoscopy to excite both autofluorescence endoscopic imaging and Raman spectroscopy. NIR autofluorescence and Raman signals are documented for each lesion examined. In addition, one biopsy is taken from each lesion identified and submitted for histopathology reporting (gold standard). In the event that no lesions are detected, one biopsy from the GI tract is taken as control. Patients are only examined once in the study. No tissue samples are stored.

What are the possible benefits and risks of participating?
The laser power used in this study is less than the American National Standards Institute (ANSI) maximum permissible skin exposure limit, and the NIR autofluorescence and Raman signal collection will be finished in a few seconds. There is no risk for the patients.

Where is the study run from?
Endoscope Center at the National University Health System (Singapore)

When is the study starting and how long is it expected to run for?
June 2010 to June 2020

Who is funding the study?
1. National Medical Research Council (Singapore)
2. National Research Foundation-Prime Minister's office (Singapore)
3. Ministry of Education (Singapore)

Who is the main contact?
1. Professor Khek Yu Ho (public)
mdchoky@nus.edu.sg
2. Associate Professor Zhiwei Huang (scientific)
biehzw@nus.edu.sg

Trial website

Contact information

Type

Public

Primary contact

Professor Khek Yu Ho

ORCID ID

Contact details

Department of Medicine
National University Hospital
Singapore
Singapore
119228
Singapore
(65) 67724353
mdchoky@nus.edu.sg

Type

Scientific

Additional contact

Associate Professor Zhiwei Huang

ORCID ID

Contact details

Department of Biomedical Engineering
National University of Singapore
Singapore
Singapore
117575
Singapore
(65) 65168856
biehzw@nus.edu.sg

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Development of near-infrared Raman and autofluorescence imaging endoscopy for optical diagnosis of lesions in gastrointestinal tracts

Acronym

Study hypothesis

The hypothesis of this study is that combining the near-infrared (NIR) Raman spectroscopy with NIR autofluorescence imaging has the potential to improve early detection and diagnosis of gastrointestinal cancer and early cancer during clinical endoscopic examination.

The aims of this study are:
1. To develop a novel NIR autofluorescence endoscopic imaging system in combination with Raman spectroscopy technique for effective in vivo tissue diagnosis in the GI tract
2. To investigate the ability of native tissue fluorescence and Raman spectroscopy under NIR excitation light to differentiate lesions from normal tissues in the GI tract
3. To determine if the NIR autofluorescence/reflectance imaging technique can be used to make in vivo diagnosis of upper GI lesions

Ethics approval

Domain Specific Review Board (DSRB), National Health Group, Singapore, 24/06/2010, ref: DSRB ref B/05/010

Study design

This is a prospective study for the development of a novel, more sensitive and superior NIR ] autofluorescence endoscopic imaging system in combination with Raman spectroscopy technique for the in vivo diagnosis of GI lesions in patients.

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Gastrointestinal (GI) lesions

Intervention

Patients will first be administered a mild sedative as used in conventional gastroscopic examinations. The upper GI tract will be carefully inspected under white light endoscopy. White light endoscopic findings based on tissue morphology will be documented. Observation of the mucosa morphology will be classified as normal mucosa, nonspecific inflammatory mucosa or abnormal mucosa. Autofluorescence endoscopic imaging and Raman spectroscopy under near-infrared (NIR) excitation light will then be carried out on the same tissue sites. NIR autofluorescence and Raman signals will be documented for each specific lesion examined. In addition, one biopsy will be taken from each lesion identified and submitted for histopathology reporting (gold standard). In the event that no lesions are detected, one biopsy from the upper gastrointestinal (GI) tract will be taken as control. Diagnostic sensitivity and specificity of NIR autofluorescence endoscopic imaging and Raman spectroscopy will be documented. Patients will only be examined once in the study. No tissue samples will be stored.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Diagnostic sensitivity and specificity of near-infrared autofluorescence imaging and/or Raman spectroscopy for upper gastrointestinal (GI) lesions

Secondary outcome measures

Predicative sensitivity and specificity of near-infrared autofluorescence imaging and/or Raman spectroscopy for upper gastrointestinal (GI) lesions

Overall trial start date

25/06/2010

Overall trial end date

24/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. The subject is undergoing endoscopy for suspected or known GI lesions such as peptic ulcer, gastritis, intestinal metaplasia, dysplasia, gastric cancer, reflux oesophagitis, Barrett’s oesophagus or oesophageal cancer
2. 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
3. The subject must be willing and able to comply with all study procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated
2. The subject with liver cirrhosis
3. 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
4. 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
5. 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
6. The subject is unwilling or unable to provide signed informed consent

Recruitment start date

25/06/2010

Recruitment end date

24/06/2015

Locations

Countries of recruitment

Singapore

Trial participating centre

Endoscope Center at the National University Health System
Singapore

Sponsor information

Organisation

National Medical Research Council, Singapore

Sponsor details

The National Medical Research Council (NMRC)
11 Biopolis Way
-
138667
Singapore

Sponsor type

Research council

Website

Organisation

National Research Foundation-Proof-of-Concept

Sponsor details

1 Create Way
#12-02 Create Tower
-
138602
Singapore

Sponsor type

Government

Website

Organisation

Academic Research Fund from Ministry of Education

Sponsor details

1 North Buona Vista Drive
-
138675
Singapore

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Medical Research Council

Alternative name(s)

NMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Singapore

Funder name

National Research Foundation-Prime Minister's office, Republic of Singapore

Alternative name(s)

National Research Foundation-Prime Minister's office, Republic of Singapore, Singapore National Research Foundation, National Research Foundation of Singapore, National Research Foundation, Singapore, NRF

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Singapore

Funder name

Ministry of Education - Singapore

Alternative name(s)

MOE

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Singapore

Results and Publications

Publication and dissemination plan

1. The diagnostic and predictive accuracy, sensitivity and specificity of Raman spectroscopy for the diagnosis of upper GI lesions will be analyzed and published
2. The diagnosis yield of Raman spectroscopy will be evaluated and compared with the routinely used endoscopic examinations techniques
3. The diagnostic and predictive accuracy, sensitivity and specificity of NIR autofluorescence imaging for the diagnosis of upper GI lesions will be analyzed and published
4. The diagnosis yield of NIR autofluorescence imaging will be evaluated and compared with the routinely used endoscopic examinations techniques
5. The diagnostic and predictive accuracy, sensitivity and specificity of NIR autofluorescence imaging combined with Raman spectroscopy for the diagnosis of upper GI lesions will be analyzed and published
6. The diagnosis yield of NIR autofluorescence imaging combined with Raman spectroscopy will be evaluated and compared with the routinely used endoscopic examinations techniques

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes