- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398121
NBI in Oral Cavity Cancer
Narrow Band Imaging in Oral Cavity Cancer-defining the Tumour Border
Oral cancer starts in the mucosa of the mouth and the most common site is the tongue and gingiva. One of the most important issues for the prognosis is to surgically remove all the cancer, at the sides as well as at the deep margin. To accomplish that, it is crucial to identify the border between tumour and healthy tissue. Traditionally white light from a head light or operation theatre lamp is used to illuminate the area of the tumour. Narrow Band Imaging (NBI) is an optical technique where ordinary white light is filtered so only the blue light in it is used. Illuminating the mucosa with this blue light through an endoscope with high definition image, makes the blood vessels appear more clearly. The altered blood vessels that the cancer produce can thereby be seen and mark the area where the tumour starts.
This study examines if NBI is helpful in the decision of where the border between the cancer and the normal mucosa is. If so, NBI might improve the possibility to remove all cancer tissue compared to using the ordinary white light.
This study will also increase the knowledge about the NBI technique, which is helpful in the examination of patients with suspected head and neck cancers and at the follow-up of patients after treatment.
Participants are patients with oral cancer presenting at the otorhinolaryngology department in Örebro University hospital in Sweden for surgical treatment. The surgery will be done in the usual fashion but the mucosa surrounding the tumour will also be illuminated by NBI and this picture of the vessels will be compared to the microscopic analysis by the pathologist, the so called PAD. Thereby we seek to compare the border in white light to the border seen with NBI.
Study Overview
Status
Conditions
Detailed Description
Patients with primary oral cavity cancer will be examined with Narrow Band Imaging (NBI) at the time of surgery. Olympus® equipment will be used together with straight 5,9 mm endoscopes.
First the tumour border seen in white light will be defined. Thereafter endoscopic examination with white light and NBI will be performed and recorded. Then the tumour border seen in white light will be marked with dots by monopolar diathermy. Finally the area is examined again with NBI and if the tumour border is seen outside the border seen in white light, that area is marked by a suture for the pathology report.
Since the purpose of this study is to gain knowledge of NBI in oral cavity cancer, the resection margin will be marked at least 10mm from the tumour border as it is seen in white light in the ordinary fashion. However there are evolving evidence that NBI better delineate tumour border in larynx and some data for the oral cavity, therefore any suspected mucosa according to NBI outside the ordinary resection margin will be included with a small margin.
There is no uniform definition of the NBI pattern in oral cavity cancer. The planned criteria is changed IPCL type III/IV according to Takano (see ref.) and so called "marked brown dots" as criteria for precancerous or cancerous mucosa according to NBI.
The tumour border in white light and NBI will be compared and PAD is considered gold standard.
To reach 80% power with 5 % type 1 error, two-sided test, and 25% of the examinations anticipated to show different tumour border with NBI, 49 participants will be needed.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Olof Nilsson, MD
- Phone Number: +46(0)196021000
- Email: olof.nilsson@regionorebrolan.se
Study Locations
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Örebro, Sweden, 70185
- Recruiting
- Orebro University Hospital
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Contact:
- Olof Nilsson, MD
- Phone Number: +46(0)196021000
- Email: olof.nilsson@regionorebrolan.se
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Principal Investigator:
- Olof Nilsson, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Biopsy proven squamous cell carcinomaI. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02-C06.
Exclusion Criteria:
- former extensive surgery in the oral cavity that effects the examination
- former radiation to the oral cavity
- patients not suitable for surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NBI tumour border
Time Frame: 4 weeks
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the possibility to determine the tumour border in the mucosa with NBI compared to white light.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Johan Knutsson, Assoc. Prof., Region Örebro County
Publications and helpful links
General Publications
- Takano JH, Yakushiji T, Kamiyama I, Nomura T, Katakura A, Takano N, Shibahara T. Detecting early oral cancer: narrowband imaging system observation of the oral mucosa microvasculature. Int J Oral Maxillofac Surg. 2010 Mar;39(3):208-13. doi: 10.1016/j.ijom.2010.01.007. Epub 2010 Feb 24.
- Ni XG, He S, Xu ZG, Lu N, Gao L, Yuan Z, Zhang YM, Lai SQ, Yi JL, Wang XL, Zhang L, Li XY, Wang GQ. [Application of narrow band imaging endoscopy in the diagnosis of laryngeal cancer]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2010 Feb;45(2):143-7. Chinese.
- Piazza C, Del Bon F, Paderno A, Grazioli P, Perotti P, Barbieri D, Majorana A, Bardellini E, Peretti G, Nicolai P. The diagnostic value of narrow band imaging in different oral and oropharyngeal subsites. Eur Arch Otorhinolaryngol. 2016 Oct;273(10):3347-53. doi: 10.1007/s00405-016-3925-5. Epub 2016 Feb 15.
- Farah CS. Narrow Band Imaging-guided resection of oral cavity cancer decreases local recurrence and increases survival. Oral Dis. 2018 Mar;24(1-2):89-97. doi: 10.1111/odi.12745.
- Tirelli G, Piovesana M, Marcuzzo AV, Gatto A, Biasotto M, Bussani R, Zandona L, Giudici F, Boscolo Nata F. Tailored resections in oral and oropharyngeal cancer using narrow band imaging. Am J Otolaryngol. 2018 Mar-Apr;39(2):197-203. doi: 10.1016/j.amjoto.2017.11.004. Epub 2017 Nov 10.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 273124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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