Lung DiseasesNCT05759390
Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions
An observational study of Lung Diseases, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Ultrasound elastography
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Radiographic evidence of pulmonary lesions
Who cannot join
- Patients less than 18 years.
- Patients refusing to participate in the study.
- Inability to hold breath for at least 5 s.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- Ultrasound elastography
- Keywords
- Ultrasound elastography, lung lesions
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound elastographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Jun 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed Gamal Elddin, Lecturer, Principal investigator, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759390
- Sponsor's protocol ID
- Elastography in Lung
- Status last verified
- Aug 2024
- First submitted
- 26 Feb 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31151959Bedawi 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.
PubMed 33650525
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound Elastography in Differentiation of Peripheral Lung Lesions
- ClinicalTrials.gov ID
- NCT05759390
- Acronym / sponsor ID
- Elastography in Lung
- Conditions
- Lung Diseases
- Keywords
- Ultrasound elastography, lung lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Radiographic evidence of pulmonary lesions
Key exclusion criteria (3 listed)
- Patients less than 18 years.
- Patients refusing to participate in the study.
- Inability to hold breath for at least 5 s.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound elastographyUsing 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 31151959Jiang 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.
- Background: PubMed 33650525Bedawi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Gamal Elddin, Lecturer principal investigator
Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the predictive value of transthoracic 2 Dimension- Shear Wave Elastography (2D-SWE) in the diagnosis of peripheral lung lesions. (time frame: 1 MONTH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.