Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus (MuSE)

Prospective Pilot Cohort Study to Assess Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus

Multispectral imaging represents an exciting new field of investigation in endoscopic research. Multispectral imaging uses a specialised camera to detect multiple colours, allowing us to build a rough spectrum from each point in our image. It is widely reported that these spectra are different for different tissue types, but this is difficult to study ex vivo since de-oxygenation of the blood and decay of the tissue change these spectra considerably.

The investigators have therefore designed this study to asses the different multispectral imaging spectra of Barrett's Oesophagus, which we believe might be utilised as a method to detect dysplasia in the future.

Study Overview

• Status: Completed
• Conditions: Esophageal Neoplasms; Barrett Esophagus; Reflux Esophagitis
• Intervention / Treatment: Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source

Detailed Description

The investigators have developed a custom multispectral endoscopes based around a CE marked device, the PolyScope disposable endoscope (PolyDiagnost). This is a combined sterile catheter and fibre optic device designed to optimize light delivery to the anatomy and to acquire and transmit endoscopic images back to a camera. This CE marked system can be used to endoscope luminal organs such as the oesophagus, but also biliary tract, the bladder and the oro-pharynx.

The PolyScope can be inserted thought the accessory channel of commercial endoscopes. The design of the fibre optic device is durable and re-useable; it is inserted within the disposable sterile catheter channel, which is able to flex and bend to orient the device to the region of interest for imaging. The fibre optic device never comes into contact with the patient. The sterile catheter, which shields the fibre optic device, is disposed following a procedure.

The use of the PolyScope provides the advantage of building on a known system. The commercial PolyScope probe is coupled outside of the patient to a custom multispectral detection and illumination system. No modified part of the device comes into contact with the patient.

The patients recruited to this study will have a clinical indication to an endoscopic examination for Barrett's oesophagus or early oesophageal adenocarcinoma. There will not be extra procedures involved. The experimental part of the procedure, using Polyscope multispectral endoscope will prolong the procedure in most cases by approximately 5-10 minutes

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0XZ
    • MRC Cancer Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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 esophageal 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, and,
• 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: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Barrett's Esophagus patients; Multi-Spectral Endoscopic Imaging	Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source; During surveillance endoscopy procedure, the endoscopist will insert the multispectral endoscopy probe through the working channel and use this to inspect the Barrett's oesophagus segment and any visible lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of confidence in delineating the area of interest by multispectral imaging	Level of confidence in delineating the area of interest by the multispectral endoscope in terms of image quality and visibility of area of interest assessed by endoscopist using a 1 to 10 Visual Analogue Score (VAS). We will consider the following ranges 0-3 poor; 4-5 fair; 6-8 good, 9-10 excellent	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging spectra by multispectral endoscopy in neoplastic vs. non-neoplastic Barrett's	Number and type of image spectra corresponding to neoplastic and non-neoplastic area of Barrett's Oesophagus	1 year
Patient comfort	Patient comfort score measured by assisting nurse according to standard scoring scale (1 to 5)	1 year
Time	Time to perform multispectral imaging in minutes	1 year
Correlation with molecular biomarkers	Comparison of the biomarker features of biopsies directed by multispectral imaging (both neoplastic and non-neoplastic) using a molecular panel assessing aneuploidy, p53 and cyclin A.	1 year

Collaborators and Investigators

• Sponsor: University of Cambridge

Publications and helpful links

General Publications

• Waterhouse DJ, Bano S, Januszewicz W, Stoyanov D, Fitzgerald RC, di Pietro M, Bohndiek SE. First-in-human pilot study of snapshot multispectral endoscopy for early detection of Barrett's-related neoplasia. J Biomed Opt. 2021 Oct;26(10):106002. doi: 10.1117/1.JBO.26.10.106002.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (ACTUAL): January 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Adenocarcinoma; Endoscopy; Barrett Esophagus
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Head and Neck Neoplasms; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Precancerous Conditions; Esophagitis, Peptic; Esophageal Neoplasms; Barrett Esophagus; Esophagitis
• Other Study ID Numbers: MuSE version 1

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