None listed
Conditions
Brief summary
The purpose of this study is to determine if an imaging method called laser confocal endomicroscopy can accurately identify the the presence of residual tumour in the margins of head and neck cancer during surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, under the care of the principal investigator with known head and neck cancer limited to the oral cavity, oropharynx or base of the tongue and requiring surgical intervention as standard therapy. Study details Participants in this study will undergo their usual surgical treatment for head and neck cancer. During this procedure the surgeon will image the tissue remaining after the tumour is removed and the researchers will also image the cancerous tissue which has been removed. The standard pathology tests will then be performed. If this study shows that laser confocal endomicroscopy can accurately determine margins in head and neck cancer then this will lead to larger clinical trials. Ultimately the aim is to give surgeons more precise tools for determining surgical margins to improve surgical outcomes for patients.
Interventions
This study compares the effectiveness of CLE-guided surgical margin assessment during and after surgery with conventional post-surgery pathology.
For CLE imaging following completion of surgery the tissue specimen is imaged ex vivo at the pathology laboratory following topical application of fluorescent dyes. The tissue is then processed as per standard of care for tissue pathology. This ex vivo CLE imaging is performed by the study researchers.
For intraoperative CLE imaging (in vivo) durin
This study compares the effectiveness of CLE-guided surgical margin assessment during and after surgery with conventional post-surgery pathology. For CLE imaging following completion of surgery the tissue specimen is imaged ex vivo at the pathology laboratory following topical application of fluorescent dyes. The tissue is then processed as per standard of care for tissue pathology. This ex vivo CLE imaging is performed by the study researchers. For intraoperative CLE imaging (in vivo) during surgery participants will receive an intravenous injection of fluorescein at time of anesthesia by the anaesthetist in the operating room (5ml 10% solution) to allow visualisation by CLE in vivo. Following resection of tumour, the defect margins (wound bed) will be imaged and recorded with in vivo CLE endoscopy. The surgeon will scan the tissue cavity using the pen-shaped CLE probe to collect microscopic images. The surgeon will perform scanning but will not be able to see the images collected as this will be overseen by the study researcher. Collection of imaging data will not impact clinical decision making, however, as this is not a standard care procedure the study is labelled as interventional for the purposes of registration. CLE imaging will only be performed on participants who enrol in the study, it is labelled . Intraoperative imaging with CLE will take no longer that 10 minutes.
Sponsors
Optiscan Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be: under the care of the principal investigator with known head and neck cancer limited to the oral cavity, oropharynx or base of the tongue and requiring surgical intervention as standard therapy.
Exclusion criteria
Exclusion criteria will include patients under 18 years of age and those who lack the capacity for informed consent. Patients with poor functional status or with cancers planned for palliative management only will also be excluded. Potential participants with a history of allergy to fluorescein or hypersensitivity responses will be excluded from the study.
Outcome results
None listed