Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Lung Diseases Clinical Trial

Official title:

Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759390
• Other study ID #: Elastography in Lung
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Waleed Gamal Elddin, Lecturer
• Phone: +201006519722
• Email: waleedgamalddin[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Advancements in imaging capacities and the development of a precise puncture-guiding transducer have made transthoracic ultrasonography a useful diagnostic tool for evaluating peripheral subpleural lung tumours. Different human tissues have varying levels of elasticity because of the properties of the extracellular matrix.

Pleural two-dimensional (2D) shear-wave elastography (SWE) can be used to differentiate between malignant pleural effusion and benign pleural disease.

Transthoracic 2D-SWE uses acoustic radiation force and assesses the velocity of tissue displacement propagation in multiple focal zones. The shear waves are monitored in 2D by creating a near-cylindrical shear-wave cone, enabling measurement of the shear-wave speed or Young's modulus (E) on a colour quantitative elastogram. Based on the hypothesis that transthoracic 2D-SWE could add accurate tissue stiffness information to B-mode grayscale ultrasound images and help in differentiating lung malignancy from benign lung lesions.

Description:

B-mode grayscale images will be used by ultrasound to assess peripheral lung lesions. Information including size, location, and intercostal chest wall thickness will be collected. Then, Investigators will use transthoracic 2D-SWE to assess those lesions.

Investigators intend to use regions of interest (ROIs) with 3-mm diameter, and select up to four ROIs with the highest mean elasticity values. the average as the final value will be calculated. If patients had multiple sub-pleural lung lesions, the largest and the most approachable one will be chosen to perform 2D-SWE. Final diagnosis will be made via appropriate diagnostic modalities including computed tomography of chest, microbiological results and guided biopsies if indicated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Radiographic evidence of pulmonary lesions

Exclusion Criteria:

• Patients less than 18 years.

• Patients refusing to participate in the study.

• Inability to hold breath for at least 5 s.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Diagnostic Test:
• Ultrasound elastography
Using an ultrasound scanner for chest ultrasound examinations. If patients has multiple sub pleural lung lesions, the largest and most approachable lesion to perform 2 Dimensions- shear wave elastography (2D-SWE) will be chosen.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Bedawi EO, Guinde J, Rahman NM, Astoul P. Advances in pleural infection and malignancy. Eur Respir Rev. 2021 Jan 13;30(159):200002. doi: 10.1183/16000617.0002-2020. Print 2021 Mar 31. — View Citation

Jiang B, Li XL, Yin Y, Zhang Q, Zang T, Song WS, Wang XM, Kang J, Herth FJF, Hou G. Ultrasound elastography: a novel tool for the differential diagnosis of pleural effusion. Eur Respir J. 2019 Aug 22;54(2):1802018. doi: 10.1183/13993003.02018-2018. Print 2019 Aug. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the predictive value of transthoracic 2 Dimension- Shear Wave Elastography (2D-SWE) in the diagnosis of peripheral lung lesions.	Peripheral lung lesions evaluated using 2 Dimension- Shear Wave Elastography to differentiate between benign and malignant lung lesions comparing the results to definitive diagnostic method either microbiological results and pathological specimens obtained by biopsy if indicated.	1 MONTH