Clinical trial NCT05759390: Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions
Official title: Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Keywords: Ultrasound elastography
lung lesions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged more than 18, presented with peripheral lung lesions not readily diagnosed.

ultrasound elastography used to differentiate benign from malignant lung lesions

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the predictive value of transthoracic 2 Dimension- Shear Wave Elastography (2D-SWE) in the diagnosis of peripheral lung lesions.
timeFrame: 1 MONTH
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
affiliation: Assiut university, Egypt
name: Waleed Gamal Elddin, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.