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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endoscopy
• Intervention / Treatment: Device: Hyper-Spectral Endoscopy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massimiliano Di Pietro, MD; Phone Number: +44 1223 763349; Email: md460@cam.ac.uk
• Study Contact Backup: Name: Tara Evans; Phone Number: +44 1223 763994; Email: tara.evans@nhs.net

Study Locations

• United Kingdom
  • County (optional)
    • Cambridge, County (optional), United Kingdom, CB20QQ
      • Cambridge University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Standard + Experimental Endoscopy; The endoscopist will intubate the patient with a high resolution white light endoscope (Olympus GIFH290Z or GIF-EZ1500) and thoroughly inspect the mucosal surface of the oesophagus. A careful note will be made of any visible lesion with their location, and the surrounding mucosa will be marked with cautery to localize the lesion for further hyperspectral imaging and biopsy. We will aim to identify at least two areas of interest per patient with the possibility to select more if the length of the Barrett's oesophagus allows. The endoscopist will remove the standard of care endoscope and then reintubate the patient with the experimental device and perform unbiased imaging first followed by targeted imaging of the endoscopic areas previously marked

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to perform hyperspectral imaging	Time in Minutes	During the intervention
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
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

Collaborators and Investigators

• Sponsor: University of Cambridge
• Collaborators: University of Manchester
• Investigators: Principal Investigator: Sarah Bohndiek, University of Cambridge

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: HySe trial v1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No