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

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ClinicalTrials.gov Identifier: NCT03388047
Recruitment Status : Not yet recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Barrett Esophagus Esophageal Neoplasms Reflux Esophagitis 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Prospective Pilot Cohort Study to Assess Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Patient comfort [ Time Frame: 1 year ]
    Patient comfort score measured by assisting nurse according to standard scoring scale (1 to 5)

  3. Time [ Time Frame: 1 year ]
    Time to perform multispectral imaging in minutes

  4. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388047


Contacts
Contact: Massimiliano di Pietro, MD 01223763349 md460@mrc-cu.cam.ac.uk

Sponsors and Collaborators
University of Cambridge
More Information

Responsible Party: Massimiliano di Pietro, MD, Principal Investigator, Honorary Gastroenterology Consultant, University of Cambridge
ClinicalTrials.gov Identifier: NCT03388047     History of Changes
Other Study ID Numbers: MuSE version 1
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massimiliano di Pietro, MD, University of Cambridge:
Barrett Esophagus
Endoscopy
Adenocarcinoma

Additional relevant MeSH terms:
Esophagitis
Barrett Esophagus
Esophageal Neoplasms
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Digestive System Abnormalities
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases