Oral CancerNCT04398121
NBI in Oral Cavity Cancer
An observational study of Oral Cancer, run by Region Örebro County at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 13 Aug 2020to 12 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Biopsy proven squamous cell carcinomaI. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02-C06.
Who cannot join
- former extensive surgery in the oral cavity that effects the examination
- former radiation to the oral cavity
- patients not suitable for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Oral Cancer
- Keywords
- tumour border, tumor margin, narrow band imaging, oral cancer, oral carcinoma
- Medical subject headings
- Mouth Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
NBI tumour border
the possibility to determine the tumour border in the mucosa with NBI compared to white light.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start13 Aug 2020
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Knutsson, Assoc. Prof., Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398121
- Sponsor's protocol ID
- 273124
- Status last verified
- May 2024
- First submitted
- 19 May 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymised data of the NBI-picture in relation to PAD will be shared.
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.
PubMed 20185271Ni 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.
PubMed 20398512Piazza 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.
PubMed 26879990Farah 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.
PubMed 29480612Tirelli 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.
PubMed 29150027
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Band Imaging in Oral Cavity Cancer-defining the Tumour Border
- ClinicalTrials.gov ID
- NCT04398121
- Acronym / sponsor ID
- 273124
- Conditions
- Oral Cancer
- Keywords
- tumour border, tumor margin, narrow band imaging, oral cancer, oral carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Biopsy proven squamous cell carcinomaI. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02-C06.
Key exclusion criteria (3 listed)
- former extensive surgery in the oral cavity that effects the examination
- former radiation to the oral cavity
- patients not suitable for surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NBI tumour border
Time frame: 4 weeks
the possibility to determine the tumour border in the mucosa with NBI compared to white light.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 20185271Takano 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.
- Background: PubMed 20398512Ni 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.
- Background: PubMed 26879990Piazza 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.
- Background: PubMed 29480612Farah 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.
- Background: PubMed 29150027Tirelli 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.
- Individual participant dataSharing planned: Yes. Pseudonymised data of the NBI-picture in relation to PAD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Knutsson, Assoc. Prof. principal investigator
Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NBI tumour border (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398121, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.