Barrett EsophagusRaPIDENCT03468634
Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
A study testing endoscopy in people with Barrett Esophagus and Esophageal Cancer, run by University of Exeter at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Esophageal Cancer
- What is being tested?
- endoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2023to 23 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Barrett's oesophagus
Who cannot join
- Unfit for endoscopic and biopsy assessment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, GL1 3NN
About this study
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).
Read the 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.
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Being tested
- endoscopy
- Keywords
- endoscopy, Raman spectroscopy
- Medical subject headings
- Barrett Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyDiagnostic test
Also called EGD (esophagogastro duodenoscopy), upper GI endoscopy
Oesophageal endoscopy with biopsy
| Study group | Role | What they receive |
|---|---|---|
| Adenocarcinoma | Experimental | patients diagnosed with adenocarcinoma Receives: Diagnostic Test: endoscopy |
| Squamous cell cancer | Experimental | patients diagnosed with squamous cell cancer Receives: Diagnostic Test: endoscopy |
| Other | Experimental | patients diagnosed with another condition Receives: Diagnostic Test: endoscopy |
| Barrett's oesophagus | Experimental | patients diagnosed with Barrett's oesophagus Receives: Diagnostic Test: endoscopy |
| Low-grade dysplasia | Experimental | patients diagnosed with low-grade dysplasia Receives: Diagnostic Test: endoscopy |
| High-grade dysplasia | Experimental | patients diagnosed with high-grade dysplasia Receives: Diagnostic Test: endoscopy |
| Indefinite for dysplasia | Experimental | patients where the diagnosis is unclear Receives: Diagnostic Test: endoscopy |
| no dysplasia | Experimental | patients not diagnosed with any cancer Receives: Diagnostic Test: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start21 Sep 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol, Gloucestershire Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Oliver Old, BMedSc MBChB, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468634
- Sponsor's protocol ID
- 1516/017/162347
- Other IDs
- II-LB-0315-20008
- Acronym
- RaPIDE
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27048868Kendall 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.
PubMed 12898596
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raman Probe for In-vivo Diagnostics (During Oesophageal) Endoscopy
- ClinicalTrials.gov ID
- NCT03468634
- Acronym / sponsor ID
- RaPIDE / 1516/017/162347
- Conditions
- Barrett Esophagus, Esophageal Cancer
- Keywords
- endoscopy, Raman spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of Bristol, Gloucestershire Hospitals NHS Foundation Trust
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma | Experimental | Diagnostic Test: endoscopypatients diagnosed with adenocarcinoma |
| Squamous cell cancer | Experimental | Diagnostic Test: endoscopypatients diagnosed with squamous cell cancer |
| Other | Experimental | Diagnostic Test: endoscopypatients diagnosed with another condition |
| Barrett's oesophagus | Experimental | Diagnostic Test: endoscopypatients diagnosed with Barrett's oesophagus |
| Low-grade dysplasia | Experimental | Diagnostic Test: endoscopypatients diagnosed with low-grade dysplasia |
| High-grade dysplasia | Experimental | Diagnostic Test: endoscopypatients diagnosed with high-grade dysplasia |
| Indefinite for dysplasia | Experimental | Diagnostic Test: endoscopypatients where the diagnosis is unclear |
| no dysplasia | Experimental | Diagnostic Test: endoscopypatients not diagnosed with any cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Barrett's oesophagus
Key exclusion criteria (1 listed)
- Unfit for endoscopic and biopsy assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyAlso: EGD (esophagogastro duodenoscopy), upper GI endoscopyOesophageal endoscopy with biopsy | Diagnostic test | Adenocarcinoma, Barrett's oesophagus, High-grade dysplasia, Indefinite for dysplasia, Low-grade dysplasia, Other, Squamous cell cancer, no dysplasia |
Primary outcome
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.
1 secondary outcome
Diagnostic model developed (algorithm able to discriminate disease with >50% specificity and >50% sensitivity)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 27048868Isabelle 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.
- Background: PubMed 12898596Kendall 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.
- RaPIDE project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Old, BMedSc MBChB principal investigator
Gloucestershire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy in people with Barrett Esophagus and Esophageal Cancer, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety testing (no detectable damage in biopsy samples when reviewed by histopathology) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.