Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus

Endoscopy Clinical Trial

— HySE  

Official title:

Prospective Pilot Cohort Study to Assess Early Diagnostic Utility of Hyper-Spectral Endoscopy for Detection of Neoplasia in Barrett's Oesophagus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06119906
• Other study ID #: HySe trial v1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: University of Cambridge
• Contact: Massimiliano Di Pietro, MD
• Phone: +44 1223 763349
• Email: md460[@]cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the efficacy of hyperspectral endoscopic imaging to distinguish neoplasia from non-dysplastic Barrett's oesophagus in vivo. The main outcome measures are: 1) Classification of spectral patterns corresponding to neoplastic vs non-neoplastic Barrett's; 2) Image quality assessed by the endoscopist by VAS rating the level of confidence in delineating the area of interest; 3) Time to perform hyperspectral imaging; 4) Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns. Participants will firstly undergo a standard endoscopy, followed by another endoscopy using the experimental HySe device. Subsequently, patients will receive biopsies according to Seattle protocol, and up to 6 additional (optional) snap frozen research biopsies.

Description:

This trial is designed to evaluate the feasibility of hyperspectral endoscopic imaging in vivo. The team has developed a custom hyperspectral endoscope based around a commercially available, standard-of-care endoscopy stack from Olympus (Tokyo, Japan). In this system, the original gastroscope, video processor and display are used with a modified light source that incorporates a laser with tunable wavelength for illuminating the scene through the endoscope. A live video feed from the gastroscope is displayed on the endoscopy theatre monitors and can be acquired and saved in the native video acquisition system. Given that it is essential in the pilot study to assess the detection of neoplastic lesions in a small patient cohort, we will artificially enrich for patients with early neoplasia by including patients with previously recognized early neoplasia within Barrett's oesophagus (high grade dysplasia and intramucosal adenocarcinoma). These patients will receive a clinically indicated endoscopy to be assessed to determine eligibility for endoscopic treatment, and imaging would be done at this time point. This will allow the team to have sufficient number of outcomes to have preliminary data on diagnostic accuracy and be able to power future studies in non-enriched patient cohorts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects over 18 years.
• Previous diagnosis of Barrett's oesophagus, with an endoscopic length of at least 2 cm if circumferential (C=2 according to Prague classification) or 3 cm if not circumferential (maximal extent M=3, according to Prague classification).
• Previous diagnosis of oesophageal glandular dysplasia or early oesophageal adenocarcinoma for consideration of endoscopic therapy.

Exclusion Criteria:

• History of oesophageal stricture precluding passage of the endoscope.
• Pregnancy, or planned pregnancy during the course of the study.
• Currently breastfeeding.
• Any history of oesophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B & C) or evidence of varices on initial treatment endoscopy.
• Any history of oesophageal surgery, except for uncomplicated fundoplication.
• History of coagulopathy, with INR>1.3 and/or platelet count of <75,000.
• On clopidogrel, and/or warfarin for high risk condition and unable to withhold temporarily the medication.

Related Conditions & MeSH terms

• Barrett Esophagus
• Endoscopy

Intervention

Device:
• Hyper-Spectral Endoscopy
We have developed a custom hyperspectral endoscopy approach based around a commercially available endoscopy system. An Olympus gastroscope (GIF-H260) and video processor and display are used with a modified light source that incorporates a laser with tunable wavelength for illuminating the scene through the endoscope. A live video feed from the gastroscope is displayed on the endoscopy monitors and can be acquired and saved in the native video acquisition system. The spectral imaging data is also saved within this video feed, where imaging wavelength corresponds to a given timestamp in the video.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospital	Cambridge	County (optional)

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast of neoplastic vs non-neoplastic Barrett's	Pixel intensity value at 16 different wave lengths in endoscopic areas of interest as compared with standard-of-care RGB white light endoscopy	Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure
Secondary	Image quality of Hyper-Spectral Endoscopy in vivo	Visual analogue scale (VAS) rating the level of confidence in delineating the area of interest	Immediately after the intervention
Secondary	Time to perform hyperspectral imaging	Time in Minutes	During the intervention
Secondary	Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns	Intensity of staining of Immunohistochemical markers	Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure
Secondary	Image quality of Hyper-Spectral Endoscopy after post-hoc analysis	Visual analogue scale (VAS) rating the level of confidence in delineating the area of interest	Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure