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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Malignant Airway Obstruction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yayi He, Ph.D, MD; Phone Number: +8621 65115006; Email: 2250601@qq.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

HIGH RISK OF CENTRAL TYPE OF LUNG CANCER

Description

Inclusion Criteria:

- Patients had a history or current central lung cancer

Exclusion Criteria:

- NONE

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Publications and helpful links

General 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.
• 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.
• 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):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.
• 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, 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Respiratory Insufficiency; Lung Neoplasms; Airway Obstruction
• Other Study ID Numbers: YHe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No