NBI in Oral Cavity Cancer

NCT04398121 | Completed

• 1 other identifier: 273124
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Oral Cancer

Keywords

tumour border; tumor margin; narrow band imaging; oral cancer; oral carcinoma

Outcome Measures

Primary Outcomes (1)

• NBI tumour border

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

  4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Biopsy proven squamous cell carcinomaI. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02-C06.

You may not qualify if:

• former extensive surgery in the oral cavity that effects the examination
• former radiation to the oral cavity
• patients not suitable for surgery

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (5)

• 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.

  PMID: 20185271 BACKGROUND

• 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.

  PMID: 20398512 BACKGROUND

• 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.

  PMID: 26879990 BACKGROUND

• 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.

  PMID: 29480612 BACKGROUND

• 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.

  PMID: 29150027 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Johan Knutsson, Assoc. Prof.

  Region Örebro County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 21, 2020
• Study Start: August 13, 2020
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

SE (1)