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

Lung Cancer Clinical Trial

Official title:

Application of Narrow Band Imaging (NBI) Under Electronic Bronchoscope in the Diagnosis and Staging of Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04676815
• Other study ID #: YHe
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, Ph.D, MD
• Phone: +8621 65115006
• Email: 2250601[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients had a history or current central lung cancer

Exclusion Criteria:

• NONE

Related Conditions & MeSH terms

• Airway Obstruction
• Lung Cancer
• Lung Neoplasms
• Malignant Airway Obstruction

Intervention

Procedure:
• NBI and interventional bronchoscopy
NBI used to enhance the contrast between the mucosal surface and underlying blood vessels

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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 — View Citation

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. — View Citation

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 performa — View Citation

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 mag — View Citation

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 No — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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