Clinical trial NCT03468634: Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
Official title: Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Esophageal Cancer
Keywords: endoscopy
Raman spectroscopy
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University of Bristol
name: Gloucestershire Hospitals NHS Foundation Trust
First posted: 2018-03-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Barrett's oesophagus

Exclusion Criteria:

* Unfit for endoscopic and biopsy assessment

Primary outcomes:
measure: Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)
timeFrame: 6 months
Secondary outcomes:
measure: Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)
timeFrame: 6 months
Other outcomes:
Locations:
city: Gloucester
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
state: Gloucestershire
Study officials:
affiliation: Gloucestershire Hospitals NHS Foundation Trust
name: Oliver Old, BMedSc MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.