Lung CancerNCT04676815
Narrow Band Imaging (NBI) Under Electronic Bronchoscope in Lung Cancer
An observational study of Lung Cancer and Malignant Airway Obstruction, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
Narrow-Band Imaging (NBI) is useful to better demarcate the superficial extent of central type of lung cancer, but its sensitivity and specificity in clinical practice were little studied. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Malignant Airway Obstruction
- What is being tested?
- NBI and interventional bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Jul 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIGH RISK OF CENTRAL TYPE OF LUNG CANCER
Who may be able to join
- Patients had a history or current central lung cancer
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pulmonary Hospital
Shanghai, 200433
Yayi He, Ph.D, +8621 65115006, 2250601@qq.com
Yayi He, Ph.D
About this study
Official title: Application of Narrow Band Imaging (NBI) Under Electronic Bronchoscope in the Diagnosis and Staging of Lung Cancer
Narrow-Band Imaging (NBI) is useful to better demarcate the superficial extent of central type of lung cancer, but its sensitivity and specificity in clinical practice were little studied. This study aimed to investigate the diagnostic effects of NBI in suspected patients with central lung cancer and its application in staging diagnosis of central lung cancer.
Read the detailed description
With high morbidity and mortality, lung cancer is one of the most common tumors in the world. Therefore, early detection, accurate diagnosis and staging division can effectively guide clinical interventions, thereby improving patient survival. Narrowband imaging under electronic bronchoscope (NBI) is an emerging optical image emphasis technology that can enhance the contrast between the mucosal surface and underlying blood vessels, specifically display the distribution of blood vessels, and highlight the subtle changes in mucosal structure. Meanwhile, it can reduce unnecessary biopsy with low risk and costs. In recent years, NBI technology has gradually begun to show its unique advantages in the diagnosis of gastric cancer, esophageal cancer, nasopharyngeal cancer, and bladder cancer. The purpose of this study is to explore the diagnostic value of NBI under electronic bronchoscopy for early detection and accurate diagnosis of lung cancer, and to provide a more economical, safer and more efficient diagnosis option for lung cancer patients.
- Conditions
- Lung Cancer, Malignant Airway Obstruction
- Being tested
- NBI and interventional bronchoscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI and interventional bronchoscopyProcedure or surgery
NBI used to enhance the contrast between the mucosal surface and underlying blood vessels
| Study group | Role | What they receive |
|---|---|---|
| NBI PATIENT | Diagnostic Test: NBI in combination with electronic bronchoscope Receives: Procedure: NBI and interventional bronchoscopy | |
| Non-NBI PATIENT | Diagnostic Test: Electronic bronchoscope without NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specificity of diagnosis of NBI plus electronic bronchoscopy in central type lung cancer
Abnormal blood vessels or lack of staining is defined as suspected lesions. All the suspected lesions were biopsied.
Measured: 4 months
Secondary outcomes (1)
The sensitivity, positive predictive value, and negative predictive value.
Abnormal blood vessels or lack of staining is defined as suspected lesions. All the suspected lesions were biopsied.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yayi He, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676815
- Sponsor's protocol ID
- YHe
- Status last verified
- May 2023
- First submitted
- 16 Dec 2020
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wen S, Dai L, Wang L, Wang W, Wu D, Wang K, He Z, Wang A, Chen H, Zhang P, Dong X, Dong YA, Wang K, Yao M, Wang M. Genomic Signature of Driver Genes Identified by Target Next-Generation Sequencing in Chinese Non-Small Cell Lung Cancer. Oncologist. 2019 Nov;24(11):e1070-e1081. doi: 10.1634/theoncologist.2018-0572. Epub 2019 Mar 22.
PubMed 30902917Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher DJ, Chung SC, Curado MP, Dandona L, Dandona R, das Neves J, Dey S, Dharmaratne SD, Doku DT, Driscoll TR, Dubey M, Ebrahimi H, Edessa D, El-Khatib Z, Endries AY, Fischer F, Force LM, Foreman KJ, Gebrehiwot SW, Gopalani SV, Grosso G, Gupta R, Gyawali B, Hamadeh RR, Hamidi S, Harvey J, Hassen HY, Hay RJ, Hay SI, Heibati B, Hiluf MK, Horita N, Hosgood HD, Ilesanmi OS, Innos K, Islami F, Jakovljevic MB, Johnson SC, Jonas JB, Kasaeian A, Kassa TD, Khader YS, Khan EA, Khan G, Khang YH, Khosravi MH, Khubchandani J, Kopec JA, Kumar GA, Kutz M, Lad DP, Lafranconi A, Lan Q, Legesse Y, Leigh J, Linn S, Lunevicius R, Majeed A, Malekzadeh R, Malta DC, Mantovani LG, McMahon BJ, Meier T, Melaku YA, Melku M, Memiah P, Mendoza W, Meretoja TJ, Mezgebe HB, Miller TR, Mohammed S, Mokdad AH, Moosazadeh M, Moraga P, Mousavi SM, Nangia V, Nguyen CT, Nong VM, Ogbo FA, Olagunju AT, Pa M, Park EK, Patel T, Pereira DM, Pishgar F, Postma MJ, Pourmalek F, Qorbani M, Rafay A, Rawaf S, Rawaf DL, Roshandel G, Safiri S, Salimzadeh H, Sanabria JR, Santric Milicevic MM, Sartorius B, Satpathy M, Sepanlou SG, Shackelford KA, Shaikh MA, Sharif-Alhoseini M, She J, Shin MJ, Shiue I, Shrime MG, Sinke AH, Sisay M, Sligar A, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tessema GA, Topor-Madry R, Tran TT, Tran BX, Ukwaja KN, Vlassov VV, Vollset SE, Weiderpass E, Williams HC, Yimer NB, Yonemoto N, Younis MZ, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706.
PubMed 29860482Subramanian V, Ragunath K. Advanced endoscopic imaging: a review of commercially available technologies. Clin Gastroenterol Hepatol. 2014 Mar;12(3):368-76.e1. doi: 10.1016/j.cgh.2013.06.015. Epub 2013 Jun 28.
PubMed 23811245Ueda T, Dohi O, Naito Y, Yoshida T, Azuma Y, Ishida T, Matsumura S, Kitae H, Takayama S, Mizuno N, Nakano T, Iwai N, Hirose R, Inoue K, Yoshida N, Kamada K, Uchiyama K, Ishikawa T, Takagi T, Konishi H, Nishimura A, Kishimoto M, Itoh Y. Diagnostic performance of magnifying blue laser imaging versus magnifying narrow-band imaging for identifying the depth of invasion of superficial esophageal squamous cell carcinoma. Dis Esophagus. 2021 Mar 8;34(3):doaa078. doi: 10.1093/dote/doaa078.
PubMed 32691042Ueyama H, Kato Y, Akazawa Y, Yatagai N, Komori H, Takeda T, Matsumoto K, Ueda K, Matsumoto K, Hojo M, Yao T, Nagahara A, Tada T. Application of artificial intelligence using a convolutional neural network for diagnosis of early gastric cancer based on magnifying endoscopy with narrow-band imaging. J Gastroenterol Hepatol. 2021 Feb;36(2):482-489. doi: 10.1111/jgh.15190. Epub 2020 Jul 28.
PubMed 32681536
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Narrow Band Imaging (NBI) Under Electronic Bronchoscope in the Diagnosis and Staging of Lung Cancer
- ClinicalTrials.gov ID
- NCT04676815
- Acronym / sponsor ID
- YHe
- Conditions
- Lung Cancer, Malignant Airway Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Dec 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.
Narrow-Band Imaging (NBI) is useful to better demarcate the superficial extent of central type of lung cancer, but its sensitivity and specificity in clinical practice were little studied. This study aimed to investigate the diagnostic effects of NBI in suspected patients with central lung cancer and its application in staging diagnosis of central lung cancer.
Detailed description
With high morbidity and mortality, lung cancer is one of the most common tumors in the world. Therefore, early detection, accurate diagnosis and staging division can effectively guide clinical interventions, thereby improving patient survival. Narrowband imaging under electronic bronchoscope (NBI) is an emerging optical image emphasis technology that can enhance the contrast between the mucosal surface and underlying blood vessels, specifically display the distribution of blood vessels, and highlight the subtle changes in mucosal structure. Meanwhile, it can reduce unnecessary biopsy with low risk and costs. In recent years, NBI technology has gradually begun to show its unique advantages in the diagnosis of gastric cancer, esophageal cancer, nasopharyngeal cancer, and bladder cancer. The purpose of this study is to explore the diagnostic value of NBI under electronic bronchoscopy for early detection and accurate diagnosis of lung cancer, and to provide a more economical, safer and more efficient diagnosis option for lung cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI PATIENT | – | Procedure: NBI and interventional bronchoscopyDiagnostic Test: NBI in combination with electronic bronchoscope |
| Non-NBI PATIENT | – | –Diagnostic Test: Electronic bronchoscope without NBI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIGH RISK OF CENTRAL TYPE OF LUNG CANCER
Key inclusion criteria (1 listed)
- Patients had a history or current central lung cancer
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI and interventional bronchoscopyNBI used to enhance the contrast between the mucosal surface and underlying blood vessels | Procedure or surgery | NBI PATIENT |
Primary outcome
The specificity of diagnosis of NBI plus electronic bronchoscopy in central type lung cancer
Time frame: 4 months
Abnormal blood vessels or lack of staining is defined as suspected lesions. All the suspected lesions were biopsied.
1 secondary outcome
The sensitivity, positive predictive value, and negative predictive value.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 30902917Wen S, Dai L, Wang L, Wang W, Wu D, Wang K, He Z, Wang A, Chen H, Zhang P, Dong X, Dong YA, Wang K, Yao M, Wang M. Genomic Signature of Driver Genes Identified by Target Next-Generation Sequencing in Chinese Non-Small Cell Lung Cancer. Oncologist. 2019 Nov;24(11):e1070-e1081. doi: 10.1634/theoncologist.2018-0572. Epub 2019 Mar 22.
- Results publication: PubMed 29860482Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Akinyemiju TF, Al Lami FH, Alam T, Alizadeh-Navaei R, Allen C, Alsharif U, Alvis-Guzman N, Amini E, Anderson BO, Aremu O, Artaman A, Asgedom SW, Assadi R, Atey TM, Avila-Burgos L, Awasthi A, Ba Saleem HO, Barac A, Bennett JR, Bensenor IM, Bhakta N, Brenner H, Cahuana-Hurtado L, Castaneda-Orjuela CA, Catala-Lopez F, Choi JJ, Christopher DJ, Chung SC, Curado MP, Dandona L, Dandona R, das Neves J, Dey S, Dharmaratne SD, Doku DT, Driscoll TR, Dubey M, Ebrahimi H, Edessa D, El-Khatib Z, Endries AY, Fischer F, Force LM, Foreman KJ, Gebrehiwot SW, Gopalani SV, Grosso G, Gupta R, Gyawali B, Hamadeh RR, Hamidi S, Harvey J, Hassen HY, Hay RJ, Hay SI, Heibati B, Hiluf MK, Horita N, Hosgood HD, Ilesanmi OS, Innos K, Islami F, Jakovljevic MB, Johnson SC, Jonas JB, Kasaeian A, Kassa TD, Khader YS, Khan EA, Khan G, Khang YH, Khosravi MH, Khubchandani J, Kopec JA, Kumar GA, Kutz M, Lad DP, Lafranconi A, Lan Q, Legesse Y, Leigh J, Linn S, Lunevicius R, Majeed A, Malekzadeh R, Malta DC, Mantovani LG, McMahon BJ, Meier T, Melaku YA, Melku M, Memiah P, Mendoza W, Meretoja TJ, Mezgebe HB, Miller TR, Mohammed S, Mokdad AH, Moosazadeh M, Moraga P, Mousavi SM, Nangia V, Nguyen CT, Nong VM, Ogbo FA, Olagunju AT, Pa M, Park EK, Patel T, Pereira DM, Pishgar F, Postma MJ, Pourmalek F, Qorbani M, Rafay A, Rawaf S, Rawaf DL, Roshandel G, Safiri S, Salimzadeh H, Sanabria JR, Santric Milicevic MM, Sartorius B, Satpathy M, Sepanlou SG, Shackelford KA, Shaikh MA, Sharif-Alhoseini M, She J, Shin MJ, Shiue I, Shrime MG, Sinke AH, Sisay M, Sligar A, Sufiyan MB, Sykes BL, Tabares-Seisdedos R, Tessema GA, Topor-Madry R, Tran TT, Tran BX, Ukwaja KN, Vlassov VV, Vollset SE, Weiderpass E, Williams HC, Yimer NB, Yonemoto N, Younis MZ, Murray CJL, Naghavi M. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2018 Nov 1;4(11):1553-1568. doi: 10.1001/jamaoncol.2018.2706.
- Results publication: PubMed 23811245Subramanian V, Ragunath K. Advanced endoscopic imaging: a review of commercially available technologies. Clin Gastroenterol Hepatol. 2014 Mar;12(3):368-76.e1. doi: 10.1016/j.cgh.2013.06.015. Epub 2013 Jun 28.
- Results publication: PubMed 32691042Ueda T, Dohi O, Naito Y, Yoshida T, Azuma Y, Ishida T, Matsumura S, Kitae H, Takayama S, Mizuno N, Nakano T, Iwai N, Hirose R, Inoue K, Yoshida N, Kamada K, Uchiyama K, Ishikawa T, Takagi T, Konishi H, Nishimura A, Kishimoto M, Itoh Y. Diagnostic performance of magnifying blue laser imaging versus magnifying narrow-band imaging for identifying the depth of invasion of superficial esophageal squamous cell carcinoma. Dis Esophagus. 2021 Mar 8;34(3):doaa078. doi: 10.1093/dote/doaa078.
- Results publication: PubMed 32681536Ueyama H, Kato Y, Akazawa Y, Yatagai N, Komori H, Takeda T, Matsumoto K, Ueda K, Matsumoto K, Hojo M, Yao T, Nagahara A, Tada T. Application of artificial intelligence using a convolutional neural network for diagnosis of early gastric cancer based on magnifying endoscopy with narrow-band imaging. J Gastroenterol Hepatol. 2021 Feb;36(2):482-489. doi: 10.1111/jgh.15190. Epub 2020 Jul 28.
- Individual participant dataSharing planned: Undecided
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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.
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 Lung Cancer and Malignant Airway Obstruction, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yayi He, Ph.D, MD (+8621 65115006, 2250601@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specificity of diagnosis of NBI plus electronic bronchoscopy in central type lung cancer (time frame: 4 months). 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 NCT04676815, 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 23 May 2023.