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

Study Overview
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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.

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

Conditions
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Barrett Esophagus, Esophageal Cancer

Intervention / Treatment
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* Diagnostic Test: endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Barrett's oesophagus Exclusion Criteria: Unfit for endoscopic and biopsy assessment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adenocarcinoma<br>patients diagnosed with adenocarcinoma | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: Squamous cell cancer<br>patients diagnosed with squamous cell cancer | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: Other<br>patients diagnosed with another condition | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: Barrett's oesophagus<br>patients diagnosed with Barrett's oesophagus | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: Low-grade dysplasia<br>patients diagnosed with low-grade dysplasia | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: High-grade dysplasia<br>patients diagnosed with high-grade dysplasia | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: Indefinite for dysplasia<br>patients where the diagnosis is unclear | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|
| Experimental: no dysplasia<br>patients not diagnosed with any cancer | Diagnostic Test: endoscopy<br>* Oesophageal endoscopy with biopsy<br>* Other names: upper GI endoscopy;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, Raman spectroscopy