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

NCT06119906 | Unknown

• 1 other identifier: HySe trial v1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Image quality of Hyper-Spectral Endoscopy in vivo

  Immediately after the intervention

• Time to perform hyperspectral imaging

  During the intervention

• Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns

  Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure

• Image quality of Hyper-Spectral Endoscopy after post-hoc analysis

  Post-hoc analysis after the endoscopy - time scale 6-12 months from procedure

Study Arms (1)

Standard + Experimental Endoscopy

EXPERIMENTAL

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

Interventions

Hyper-Spectral Endoscopy DEVICE

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.

Standard + Experimental Endoscopy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cambridge: lead
• University of Manchester: collaborator

Study Sites (1)

Cambridge University Hospital

Cambridge, County (optional), CB20QQ, United Kingdom

Location

Study Officials

• Sarah Bohndiek

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimiliano Di Pietro, MD

CONTACT

+44 1223 763349; md460@cam.ac.uk

Tara Evans

CONTACT

+44 1223 763994; tara.evans@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 7, 2023
• Study Start: April 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)