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

U

University of Exeter

Status

Completed

Conditions

Esophageal Cancer
Barrett Esophagus

Treatments

Diagnostic Test: endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03468634
1516/017/162347
II-LB-0315-20008 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Barrett's oesophagus

Exclusion criteria

  • Unfit for endoscopic and biopsy assessment

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 8 patient groups

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

Trial contacts and locations

1

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Central trial contact

Antony Walsh, PhD; Nicholas Stone, PhD

Data sourced from clinicaltrials.gov

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