Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy (RaPIDE)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gloucestershire
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Gloucester, Gloucestershire, United Kingdom, GL1 3NN
- Gloucestershire Hospitals NHS Foundation Trust
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Barrett's oesophagus
Exclusion Criteria:
- Unfit for endoscopic and biopsy assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adenocarcinoma
patients diagnosed with adenocarcinoma
|
Oesophageal endoscopy with biopsy
Other Names:
|
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Experimental: Squamous cell cancer
patients diagnosed with squamous cell cancer
|
Oesophageal endoscopy with biopsy
Other Names:
|
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Experimental: Other
patients diagnosed with another condition
|
Oesophageal endoscopy with biopsy
Other Names:
|
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Experimental: Barrett's oesophagus
patients diagnosed with Barrett's oesophagus
|
Oesophageal endoscopy with biopsy
Other Names:
|
|
Experimental: Low-grade dysplasia
patients diagnosed with low-grade dysplasia
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Oesophageal endoscopy with biopsy
Other Names:
|
|
Experimental: High-grade dysplasia
patients diagnosed with high-grade dysplasia
|
Oesophageal endoscopy with biopsy
Other Names:
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Experimental: Indefinite for dysplasia
patients where the diagnosis is unclear
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Oesophageal endoscopy with biopsy
Other Names:
|
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Experimental: no dysplasia
patients not diagnosed with any cancer
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Oesophageal endoscopy with biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)
Time Frame: 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. |
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)
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oliver Old, BMedSc MBChB, Gloucestershire Hospitals NHS Foundation Trust
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1516/017/162347
- II-LB-0315-20008 (Other Grant/Funding Number: NIHR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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