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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
2012 results in https://www.ncbi.nlm.nih.gov/pubmed/23243583