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

NCT06119906 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Sarah Bohndiek · University of Cambridge

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-03-31
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119906 on ClinicalTrials.gov