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

NCT ID: NCT03468634

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2024-04-23

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Barrett Esophagus Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Adenocarcinoma

patients diagnosed with adenocarcinoma

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Squamous cell cancer

patients diagnosed with squamous cell cancer

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Other

patients diagnosed with another condition

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Barrett's oesophagus

patients diagnosed with Barrett's oesophagus

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Low-grade dysplasia

patients diagnosed with low-grade dysplasia

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

High-grade dysplasia

patients diagnosed with high-grade dysplasia

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Indefinite for dysplasia

patients where the diagnosis is unclear

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

no dysplasia

patients not diagnosed with any cancer

Group Type EXPERIMENTAL

endoscopy

Intervention Type DIAGNOSTIC_TEST

Oesophageal endoscopy with biopsy

Interventions

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endoscopy

Oesophageal endoscopy with biopsy

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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EGD (esophagogastro duodenoscopy) upper GI endoscopy

Eligibility Criteria

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Inclusion Criteria

* Barrett's oesophagus

Exclusion Criteria

* Unfit for endoscopic and biopsy assessment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bristol

OTHER

Sponsor Role collaborator

Gloucestershire Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Exeter

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Old, BMedSc MBChB

Role: PRINCIPAL_INVESTIGATOR

Gloucestershire Hospitals NHS Foundation Trust

Locations

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Gloucestershire Hospitals NHS Foundation Trust

Gloucester, Gloucestershire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Isabelle M, Dorney J, Lewis A, Lloyd GR, Old O, Shepherd N, Rodriguez-Justo M, Barr H, Lau K, Bell I, Ohrel S, Thomas G, Stone N, Kendall C. Multi-centre Raman spectral mapping of oesophageal cancer tissues: a study to assess system transferability. Faraday Discuss. 2016 Jun 23;187:87-103. doi: 10.1039/c5fd00183h.

Reference Type BACKGROUND
PMID: 27048868 (View on PubMed)

Kendall C, Stone N, Shepherd N, Geboes K, Warren B, Bennett R, Barr H. Raman spectroscopy, a potential tool for the objective identification and classification of neoplasia in Barrett's oesophagus. J Pathol. 2003 Aug;200(5):602-9. doi: 10.1002/path.1376.

Reference Type BACKGROUND
PMID: 12898596 (View on PubMed)

Related Links

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Other Identifiers

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II-LB-0315-20008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1516/017/162347

Identifier Type: -

Identifier Source: org_study_id

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