Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy (RaPIDE)

April 24, 2024 updated by: University of Exeter
To develop and endoscopic Raman spectroscopy probe for delivery down and channel in an endoscope to make near instant assessments of the condition of the oesophagus without the need for expensive and distressing tissue removal (biopsies).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators have already shown that it is possible to tell the difference between healthy and diseased tissue in the laboratory by looking at the light emitted by tissue when illuminated with a low power laser. The investigators intend to use this technique, known as "Raman Spectroscopy" to tell if tissue in the oesophagus is cancerous, healthy or at some stage before full blown cancer, which is termed pre-cancer. It has been shown in the laboratory that this method will be at least as accurate as the conventional methods used now, but will provide the surgeon with instant results without the delay and cost of a laboratory analysis by pathologists.

A miniature probe has been developed that slides through a channel in the endoscope (telescope) to the surface of the oesophagus to make near instant assessments of its condition without the need for expensive and distressing tissue removal (biopsies). This project plans to move this technique from the laboratory to the clinic by demonstrating that the method is safe and reliable for use in real patients.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Barrett's oesophagus

Exclusion Criteria:

  • Unfit for endoscopic and biopsy assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adenocarcinoma
patients diagnosed with adenocarcinoma
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Squamous cell cancer
patients diagnosed with squamous cell cancer
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Other
patients diagnosed with another condition
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Barrett's oesophagus
patients diagnosed with Barrett's oesophagus
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Low-grade dysplasia
patients diagnosed with low-grade dysplasia
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: High-grade dysplasia
patients diagnosed with high-grade dysplasia
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: Indefinite for dysplasia
patients where the diagnosis is unclear
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy
Experimental: no dysplasia
patients not diagnosed with any cancer
Diagnostic test: endoscopy
Oesophageal endoscopy with biopsy
Other Names:
  • EGD (esophagogastro duodenoscopy)
  • upper GI endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)
Time Frame: 6 months

Testing of the device for clinical application to demonstrate its use is safe and that is able to acquire diagnostic-quality (see outcome 2) spectra in less than 5 seconds from within the oesophagus.

Samples illuminated will be biopsied and sent for routine histopathological analysis.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)
Time Frame: 6 months
Computer model using multivariate analysis able to discriminate between diseased and non-diseased tissue. The target specificity and sensitivity are low due to small study group sizes.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

University of Bristol
Gloucestershire Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Oliver Old, BMedSc MBChB, Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

April 23, 2024

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1516/017/162347
  • II-LB-0315-20008 (Other Grant/Funding Number: NIHR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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