NBI in Oral Cavity Cancer

NBI in Oral Cavity Cancer: Condition:   Oral Cancer

Intervention:  

Sponsor:   Region Örebro County

Not yet recruiting




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NBI in Oral Cavity Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04398121

Recruitment Status  : Not yet recruiting

First Posted  : May 22, 2020

Last Update Posted  : May 22, 2020

See Contacts and Locations

Sponsor:

Region Örebro County

Information provided by (Responsible Party):

Region Örebro County



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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Brief Summary:

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.



We seek to examine 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 give us increased 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.





Condition or disease 

Oral Cancer



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, we will mark our resection margin of 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, so we will include any suspected mucosa according to NBI in the resection.



There is no uniform definition of the NBI pattern in oral cavity cancer. We will use both 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, we will need 49 participants.



Study Design

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Study Type  : Observational

Estimated Enrollment  : 54 participants

Observational Model: Other

Time Perspective: Prospective

Official Title: Narrow Band Imaging in Oral Cavity Cancer-defining the Tumour Border

Estimated Study Start Date  : May 2020

Estimated Primary Completion Date  : December 2021

Estimated Study Completion Date  : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Genetic and Rare Diseases Information Center resources: Oral Cancer Lip and Oral Cavity Cancer

U.S. FDA Resources



Groups and Cohorts

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Outcome Measures

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Primary Outcome Measures  :

NBI tumour border [ Time Frame: 4 weeks ]

the possibility to determine the tumour border in the mucosa with NBI compared to white light.





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Sampling Method:  Non-Probability Sample

Study Population

The study population will be patients with oral cancer presenting for treatment at our clinic. All patients that meet the eligibility criteria will be asked to participate.

Criteria

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

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04398121





Contacts

Contact: Olof Nilsson, MD +46(0)196021000 olof.nilsson@regionorebrolan.se



Sponsors and Collaborators

Region Örebro County

Investigators

Principal Investigator: Johan Knutsson, Assoc. Prof. Region Örebro County

More Information

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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, Lü 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, Zandonà 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.



Responsible Party: Region Örebro County

ClinicalTrials.gov Identifier: NCT04398121     History of Changes

Other Study ID Numbers: 273124

First Posted: May 22, 2020    Key Record Dates

Last Update Posted: May 22, 2020

Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: Yes

Plan Description: Pseudonymised data of the NBI-picture in relation to PAD will be shared.

Supporting Materials: Study Protocol

Statistical Analysis Plan (SAP)

Informed Consent Form (ICF)

Clinical Study Report (CSR)

Analytic Code

Time Frame: 6 months after publication

Access Criteria: Coded, computerized IPD will be available upon a request with the serious intention to improve the scientific knowledge and transparency.

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Örebro County:

tumour border

tumor margin

narrow band imaging

oral cancer

oral carcinoma

Additional relevant MeSH terms:

Mouth Neoplasms

Head and Neck Neoplasms

Neoplasms by Site

Neoplasms

Mouth Diseases

Stomatognathic Diseases





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