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

Esophageal Cancer Clinical Trial

— RaPIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468634
• Other study ID #: 1516/017/162347
• Secondary ID: II-LB-0315-20008
• Status: Completed
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: April 23, 2024

Study information

• Verified date: April 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Barrett's oesophagus

Exclusion Criteria:

• Unfit for endoscopic and biopsy assessment

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer

Intervention

Diagnostic Test:
• endoscopy
Oesophageal endoscopy with biopsy

Locations

Country	Name	City	State
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucester	Gloucestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Exeter	Gloucestershire Hospitals NHS Foundation Trust, University of Bristol

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   RaPIDE project website