Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388047
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Massimiliano di Pietro, MD, University of Cambridge

Tracking Information
First Submitted Date  ICMJE November 23, 2017
First Posted Date  ICMJE January 2, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Level of confidence in delineating the area of interest by multispectral imaging [ Time Frame: 1 year ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Imaging spectra by multispectral endoscopy in neoplastic vs. non-neoplastic Barrett's [ Time Frame: 1 year ]
    Number and type of image spectra corresponding to neoplastic and non-neoplastic area of Barrett's Oesophagus
  • Patient comfort [ Time Frame: 1 year ]
    Patient comfort score measured by assisting nurse according to standard scoring scale (1 to 5)
  • Time [ Time Frame: 1 year ]
    Time to perform multispectral imaging in minutes
  • Correlation with molecular biomarkers [ Time Frame: 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
Official Title  ICMJE Prospective Pilot Cohort Study to Assess Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Barrett Esophagus
  • Esophageal Neoplasms
  • Reflux Esophagitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Barrett's Esophagus patients
Multi-Spectral Endoscopic Imaging
Intervention: Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Massimiliano di Pietro, MD 01223763349 md460@mrc-cu.cam.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03388047
Other Study ID Numbers  ICMJE MuSE version 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Massimiliano di Pietro, MD, University of Cambridge
Study Sponsor  ICMJE University of Cambridge
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Cambridge
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP