CompletedNot Applicable

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

United Kingdom20 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Level of confidence in delineating the area of interest by multispectral imaging

Timeframe: 1 year

Trial details

NCT IDNCT03388047

SponsorUniversity of Cambridge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Barrett Esophagus trials