NCT03388047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

November 23, 2017

Last Update Submit

April 26, 2021

Conditions

Barrett EsophagusEsophageal NeoplasmsReflux Esophagitis

Keywords

Barrett EsophagusEndoscopyAdenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Imaging spectra by multispectral endoscopy in neoplastic vs. non-neoplastic Barrett's

    1 year

  • Patient comfort

    1 year

  • Time

    1 year

  • Correlation with molecular biomarkers

    1 year

Study Arms (1)

Barrett's Esophagus patients

EXPERIMENTAL

Multi-Spectral Endoscopic Imaging

Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source

Interventions

Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-sourceDEVICE

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

Barrett's Esophagus patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC Cancer Unit

Cambridge, CB2 0XZ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34628734DERIVED

MeSH Terms

Conditions

Barrett EsophagusEsophageal NeoplasmsEsophagitis, PepticAdenocarcinoma

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEsophagitisGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Honorary Gastroenterology Consultant

Study Record Dates

First Submitted

November 23, 2017

First Posted

January 2, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)