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

Not Applicable

Completed

• Conditions: Esophageal Cancer; Barrett Esophagus
• Interventions: Diagnostic Test: endoscopy

• Registration Number: NCT03468634
• Lead Sponsor: University of Exeter

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-16
• Study Start: 2023-09-21
• Status Verified: 2024-04
• Primary Completion: 2024-04-23
• Study Completion: 2024-04-23
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Barrett's oesophagus

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Exclusion Criteria

• Unfit for endoscopic and biopsy assessment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Squamous cell cancer	endoscopy	patients diagnosed with squamous cell cancer
High-grade dysplasia	endoscopy	patients diagnosed with high-grade dysplasia
Barrett's oesophagus	endoscopy	patients diagnosed with Barrett's oesophagus
Adenocarcinoma	endoscopy	patients diagnosed with adenocarcinoma
Low-grade dysplasia	endoscopy	patients diagnosed with low-grade dysplasia
Other	endoscopy	patients diagnosed with another condition
no dysplasia	endoscopy	patients not diagnosed with any cancer
Indefinite for dysplasia	endoscopy	patients where the diagnosis is unclear

Primary Outcome Measures

Name	Time	Method
Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)	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.

Trial Locations

Locations (1)

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Gloucester, Gloucestershire, United Kingdom