Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

Completed

• Conditions: Lung Diseases

• Registration Number: NCT05759390
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-02-26
• Study First Posted: 2023-03-08
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the predictive value of transthoracic 2 Dimension- Shear Wave Elastography (2D-SWE) in the diagnosis of peripheral lung lesions.	1 MONTH	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.

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt