Condition category
Cancer
Date applied
16/08/2011
Date assigned
02/03/2012
Last edited
28/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Larynx (voicebox) cancer is one of the most common head and neck cancers. The main risk factors are smoking and drinking alcohol. Early larynx cancer can be treated by laser, which has a cure rate of over 90% and avoids the side effects of radio/chemotherapy. Later stage larynx cancer is hugely expensive to treat and wasteful of healthcare resources, often requiring mutilating treatment resulting in loss of ability to speak or swallow. Optical Coherence Tomography (OCT) is a relatively new technology where light is used to scan a tissue’s surface and a few millimetres deep into it, obtaining accurate information about the tissue’s characteristics, without the need to physically cut into tissue in order to microscopically examine if it is normal, precancerous or cancerous. We aim to test whether new OCT probes can distinguish normal from unhealthy larynx tissue and determine whether it is acceptable for clinicians and patients.

Who can participate?
Patients aged over 18 with suspicious larynx appearances on endoscopy.

What does the study involve?
Participants will have endoscopic OCT images taken before going on to have biopsies (samples) of the larynx tissue taken under anaesthetic. One pathologist will compare the OCT results with the standard biopsy results to determine the effectiveness of OCT in distinguishing cancerous from noncancerous tissue. Patient acceptability of the process will be established through a patient experience questionnaire.

What are the possible benefits and risks of participating?
Following this study we aim to use the results to develop a non-invasive, patient-friendly and safe laryngeal cancer screening tool. With this we aim to increase the early detection and treatment of larynx cancer.

Where is the study run from?
North West London Hospitals NHS Trust (UK).

When is the study starting and how long is it expected to run for?
October 2011 to February 2012.

Who is funding the study?
National Institute for Health Research (UK).

Who is the main contact?
Taran Tatla
ttatla@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mr Taran Tatla

ORCID ID

Contact details

North West London Hospitals NHS Trust
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
-
ttatla@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8939

Study information

Scientific title

Development of endoscopic optical coherence tomography for laryngeal cancer screening: a non-randomised trial

Acronym

OCTiLarynx

Study hypothesis

OCTiLarynx (Optical Coherence Tomography in Larynx). This 'proof of concept' project has a primary objective to determine if recent and continuing advances in the technology of Optical Coherence Tomography (OCT) can result in a clinically useful out-patient based diagnostic tool for endoscopic laryngeal disease screening.

We aim to validate the clinical efficacy of novel endoscopic OCT imaging probes for distinguishing normal from unhealthy laryngeal mucosa (inflamed, dysplastic, malignant) and determine clinician/patient acceptability for the same.

Ethics approval

Central London Research Ethics Committee, 28/07/2010, ref: 10/H0718/55

Study design

Non randomised trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Laryngeal cancer screening

Intervention

Clinical recruitment of up to 40 patients for in vivo study shall occur initially at a single site (Northwick Park ENT-Head & Neck Department). Patients attending the outpatient service for secondary / tertiary care consult in relation to prolonged voice change and noted to have a suspect laryngeal mucosal lesion shall be recruited prospectively for the study. Following informed consent, these patients shall have standard endoscopic digital photographic images and endoscopic OCT images of the lesions taken under topical local anaesthesia (LA) in the out-patient department. As is standard practice presently, all such patients shall then proceed on to direct biopsies of the laryngeal lesions under general anaesthesia to allow “gold standard” histological diagnosis with routine Haematoxylin and Eosin stains of wax-embedded tissue sections.

A single pathologist trained in OCT tissue imaging techniques shall make a blinded comparison, comparing and correlating the OCT diagnostic modality with the standard biopsy histological technique for distinguishing laryngeal mucosal disease category. Preliminary statistical analysis will determine the efficacy and repeatability of the OCT tool in distinguishing cancer from non-cancer. Patient acceptability of the process will be established through a patient experience questionnaire and clinician feedback shall be sought on practicality and ease of use of the endoscopic OCT tool.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Characterisation & correlation of mucosal pathology (OCT images vs Histopathology) following direct microlaryngoscopy and biopsy of laryngeal lesion under general anaesthesia (GA)

Secondary outcome measures

Patient Experience Questionnaire at initial out-patient visit , immediately following nasendoscopy examination and image capture under LA

Overall trial start date

03/10/2011

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients over the age of 18 years (no upper age limit)
2. Male or female gender
3. Patients able to provide informed consent to OCT-adapted flexible nasendoscope examination under topical local anaesthesia and completing a patient experience questionnaire provided at the end of procedure
4. Smokers and non-smokers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 40

Participant exclusion criteria

1. All patients under the age of 18 years
2. All patients from whom informed consent has not been obtained prior to tissue resection or OCT-adapted flexible nasendoscopy respectively

Recruitment start date

03/10/2011

Recruitment end date

29/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North West London Hospitals NHS Trust
London
HA1 3UJ
United Kingdom

Sponsor information

Organisation

North West London Hospitals NHS Trust (UK)

Sponsor details

Watford Road
Harrow
London
HA1 3UJ
United Kingdom
-
alanwarnes@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.nwlh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes