None listed
Conditions
Brief summary
This study will compare resection of oral cancer guided by Narrow Band Imaging with resection guided by white light panendoscopy. Who is it for? Participants over eighteen years of age with oral squamous cell carcinoma planned for surgical management will be invited to participate in the study. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have Narrow Band Imaging and white light panendoscopy prior to surgery. Participants in the other group will have examination with white light panendoscopy prior to surgery, which is routine practice. Participants will have a pre-treatment PET scan, blood sample, and MRI and a post-treatment PET scan and blood sample. All surgical specimens will be examined by a pathologist as is routine practice. The molecular profiles of resection margins will be analysed to confirm that NBI surgical resection margins are molecularly distinct from WL margins and the tumour. This information will be used to create a molecular biomarker panel for head and neck cancer. Participants will be followed-up for up to 5 years post-treatment to determine local recurrence and disease free survival. A prospective Health Economic Assessment to demonstrate the cost benefit of the use of NBI in oral cancer management will be undertaken. Known and possible side effect(s) for each arm of the trial; Applicable to both arms: - Oral squamous cell carcinoma, as well as treatments for Oral squamous cell carcinoma, have the potential to significantly affect patients’ quality of life, in particular their speech and swallowing. - There is a direct relationship between the size of the resection/complexity of reconstruction and subsequent risks (including speech/swallowing impairment). Participants in one group will not universally have larger margins resected than participants in the other group, therefore increased risk of these treatment side-effects will not be universally applicable to participants in either group.
Interventions
1) Resection of oral squamous cancer - guided by Narrow Band Imaging.
Device: Narrow Band Imaging (Olympus). Narrow Band Imaging (NBI) uses 2 narrow bands of light, one at 400-430nm and the second at 525-555nm.
Procedure: Margins around the tumour will be delineated with Narrow Band Imaging prior to tumour resection.
Resection of the oral cancer will proceed under General Anaesthesia as per usual practice. The peri-operative experience of the patient will not be altered by which group they are
1) Resection of oral squamous cancer - guided by Narrow Band Imaging. Device: Narrow Band Imaging (Olympus). Narrow Band Imaging (NBI) uses 2 narrow bands of light, one at 400-430nm and the second at 525-555nm. Procedure: Margins around the tumour will be delineated with Narrow Band Imaging prior to tumour resection. Resection of the oral cancer will proceed under General Anaesthesia as per usual practice. The peri-operative experience of the patient will not be altered by which group they are randomised to and will be no different to their experience had they undergone routine management outside of the trial. 2) Punch biopsies of tumour, NBI margin, WL margin and normal oral mucosa – guided by White Light Panendoscopy and Narrow Band Imaging. Device: Narrow Band Imaging (Olympus), White Light Endoscope (full spectrum white light with wavelength inclusive of 400-700 nm). Procedure: 5mm punch biopsies will be taken from the body of the tumour, the WL and NBI margins at 3, 6, 9 and 12 o’clock and normal tissue from the contralateral side of the oral cavity. Specifics applicable to both interventions Who: Completed by Consultant Otolarynology Head and Neck Surgeons Timing: - The interventions will occur sequentially, intra-operatively, under General Anaesthesia. Punch biopsies will be performed following margin delineation and prior to tumour resection. - Those patients in the intervention arm will have a slightly increased time required for surgical margin delineation as they will undergo both WL and NBI nasendoscopy. This said, the time taken for the procedures will not significantly alter the total time taken for the surgery. Total operative time depends on the clinical circumstance. Mode of delivery: Face-to-face, single patient at a time. Number of times: Intervention completed on a single occasion. Location: Operating Theatre, Sir Charles Gairdner Hospital, Perth, Western Australia.
Sponsors
Professor Camile Farah
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients planned for surgical management of Oral Squamous Cell Carcinoma. >18 years of age. Patients able to give informed consent.
Exclusion criteria
Oral Squamous Cell Carcinoma planned for non-operative management. <18 years of age. Patients unable to give informed consent.
Outcome results
None listed