Barrett EsophagusMuSENCT03388047
Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
A study testing Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source in people with Barrett Esophagus and Esophageal Neoplasms, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Neoplasms, Reflux Esophagitis
- What is being tested?
- Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Barrett Esophagus, Esophageal Neoplasms, Reflux Esophagitis
- Being tested
- Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source
- Keywords
- Barrett Esophagus, Endoscopy, Adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms, Esophagitis, Peptic, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Barrett's Esophagus patients | Experimental | Multi-Spectral Endoscopic Imaging Receives: Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
Patient comfort
Patient comfort score measured by assisting nurse according to standard scoring scale (1 to 5)
Measured: 1 year
Time
Time to perform multispectral imaging in minutes
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimiliano di Pietro, MD, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388047
- Sponsor's protocol ID
- MuSE version 1
- Acronym
- MuSE
- Status last verified
- Apr 2021
- First submitted
- 23 Nov 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34628734
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Cohort Study to Assess Feasibility of Multi-Spectral Endoscopic Imaging for Detection of Early Neoplasia in Barrett's Oesophagus
- ClinicalTrials.gov ID
- NCT03388047
- Acronym / sponsor ID
- MuSE / MuSE version 1
- Conditions
- Barrett Esophagus, Esophageal Neoplasms, Reflux Esophagitis
- Keywords
- Barrett Esophagus, Endoscopy, Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barrett's Esophagus patients | Experimental | Device: Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-sourceMulti-Spectral Endoscopic Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-sourceDuring 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 | Device | Barrett's Esophagus patients |
Primary outcome
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
4 secondary outcomes
Imaging spectra by multispectral endoscopy in neoplastic vs. non-neoplastic Barrett's
Time frame: 1 year
Patient comfort
Time frame: 1 year
Time
Time frame: 1 year
Correlation with molecular biomarkers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 34628734Waterhouse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source in people with Barrett Esophagus and Esophageal Neoplasms, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of confidence in delineating the area of interest by multispectral imaging (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.