Narrow Band Imaging (NBI) Under Electronic Bronchoscope in Lung Cancer

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ClinicalTrials.gov Identifier: NCT04676815

Recruitment Status : Not yet recruiting

First Posted : December 21, 2020

Last Update Posted : January 6, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Yayi He, Shanghai Pulmonary Hospital, Shanghai, China

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment
Lung Cancer Malignant Airway Obstruction	Procedure: NBI and interventional bronchoscopy

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

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Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Application of Narrow Band Imaging (NBI) Under Electronic Bronchoscope in the Diagnosis and Staging of Lung Cancer
Estimated Study Start Date :	January 2021
Estimated Primary Completion Date :	April 30, 2021
Estimated Study Completion Date :	April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
NBI PATIENT Diagnostic Test: NBI in combination with electronic bronchoscope	Procedure: NBI and interventional bronchoscopy NBI used to enhance the contrast between the mucosal surface and underlying blood vessels
Non-NBI PATIENT Diagnostic Test: Electronic bronchoscope without NBI

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

The sensitivity, positive predictive value, and negative predictive value. [ Time Frame: 4 months ]
Abnormal blood vessels or lack of staining is defined as suspected lesions. All the suspected lesions were biopsied.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

HIGH RISK OF CENTRAL TYPE OF LUNG CANCER

Criteria

Inclusion Criteria:

- Patients had a history or current central lung cancer

Exclusion Criteria:

- NONE

Contacts and Locations

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): NCT04676815

Contacts

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Contact: Yayi He, Ph.D, MD	+8621 65115006	2250601@qq.com

Locations

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China
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Contact: Yayi He, Ph.D +8621 65115006 2250601@qq.com
Principal Investigator: Yayi He, Ph.D
Principal Investigator: Ye Gu, M.D

Sponsors and Collaborators

Shanghai Pulmonary Hospital, Shanghai, China

More Information

Publications of Results:

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.

Global 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, Castañeda-Orjuela CA, Catalá-López 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, Tabarés-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.

Subramanian 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. Review.

Ueda 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). pii: doaa078. doi: 10.1093/dote/doaa078.

Ueyama 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.

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Responsible Party:	Yayi He, Associate Chief Physician, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier:	NCT04676815
Other Study ID Numbers:	YHe
First Posted:	December 21, 2020 Key Record Dates
Last Update Posted:	January 6, 2021
Last Verified:	January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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

Additional relevant MeSH terms:

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Lung Neoplasms Airway Obstruction Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site	Neoplasms Lung Diseases Respiratory Tract Diseases Respiratory Insufficiency Respiration Disorders

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