Back to results

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

Primary Purpose

Barrett Esophagus, Esophageal Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

endoscopy

About this trial

This is an interventional diagnostic trial for Barrett Esophagus focused on measuring endoscopy, Raman spectroscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Barrett's oesophagus

Exclusion Criteria:

Unfit for endoscopic and biopsy assessment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Adenocarcinoma

Squamous cell cancer

Other

Barrett's oesophagus

Low-grade dysplasia

High-grade dysplasia

Indefinite for dysplasia

no dysplasia

Arm Description

patients diagnosed with adenocarcinoma

patients diagnosed with squamous cell cancer

patients diagnosed with another condition

patients diagnosed with Barrett's oesophagus

patients diagnosed with low-grade dysplasia

patients diagnosed with high-grade dysplasia

patients where the diagnosis is unclear

patients not diagnosed with any cancer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03468634

First Posted

January 11, 2018

Last Updated

July 18, 2023

Sponsor

University of Exeter

Collaborators

University of Bristol, Gloucestershire Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03468634

Brief Title

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

Acronym

RaPIDE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Exeter

Collaborators

University of Bristol, Gloucestershire Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Barrett Esophagus, Esophageal Cancer

Keywords

endoscopy, Raman spectroscopy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adenocarcinoma

Arm Type

Experimental

Arm Description

patients diagnosed with adenocarcinoma

Arm Title

Squamous cell cancer

Arm Type

Experimental

Arm Description

patients diagnosed with squamous cell cancer

Arm Title

Other

Arm Type

Experimental

Arm Description

patients diagnosed with another condition

Arm Title

Barrett's oesophagus

Arm Type

Experimental

Arm Description

patients diagnosed with Barrett's oesophagus

Arm Title

Low-grade dysplasia

Arm Type

Experimental

Arm Description

patients diagnosed with low-grade dysplasia

Arm Title

High-grade dysplasia

Arm Type

Experimental

Arm Description

patients diagnosed with high-grade dysplasia

Arm Title

Indefinite for dysplasia

Arm Type

Experimental

Arm Description

patients where the diagnosis is unclear

Arm Title

no dysplasia

Arm Type

Experimental

Arm Description

patients not diagnosed with any cancer

Intervention Type

Diagnostic Test

Intervention Name(s)

endoscopy

Other Intervention Name(s)

EGD (esophagogastro duodenoscopy), upper GI endoscopy

Intervention Description

Oesophageal endoscopy with biopsy

Primary Outcome Measure Information:

Title

Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicholas Stone, PhD

Phone

+441392726531

n.stone@exeter.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Foy

Organizational Affiliation

Gloucestershire Hospitals NHS Foundation Trust

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nicholas Stone, PhD

Organizational Affiliation

University of Exeter

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs