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OpenTrials
Completed

NCT Number: NCT05759390

Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university hospitals

Asyut, 71515, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound Elastography

Diagnostic Test

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 8, 2023
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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