Elasticity Imaging TechniquesNCT04781894
Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions
An observational study of Elasticity Imaging Techniques, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Elasticity Imaging Techniques
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2021to 25 Jan 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving chest ultrasonography in National Taiwan University Hospital
Who may be able to join
- Patients with radiographic evidence of pleural lesions or effusion
Who cannot join
- Age < 20 y/o
- Patients who cannot hold their breath for 5 seconds
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yao-Wen Kuo, MD, 0972-651-821, kyw@ntu.edu.tw
Yao-Wen Kuo, MD
About this study
This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.
- Conditions
- Elasticity Imaging Techniques
- Keywords
- Shear wave ultrasound elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
Application of transthoracic shear-wave ultrasound elastography in pleural lesions
to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start10 Feb 2021
- Primary completion25 Jan 2025 (estimated)
- Study completion25 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elasticity Imaging TechniquesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781894
- Sponsor's protocol ID
- 202012200RINA
- Status last verified
- Aug 2024
- First submitted
- 1 Mar 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transthoracic Shear-wave Ultrasound Elastography in Pleural Lesions
- ClinicalTrials.gov ID
- NCT04781894
- Acronym / sponsor ID
- 202012200RINA
- Conditions
- Elasticity Imaging Techniques
- Keywords
- Shear wave ultrasound elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 25 Jan 2025 (estimated)
- First posted
- 4 Mar 2021 (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.
This study aims to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chest ultrasonography in National Taiwan University Hospital
Key inclusion criteria (1 listed)
- Patients with radiographic evidence of pleural lesions or effusion
Key exclusion criteria (2 listed)
- Age < 20 y/o
- Patients who cannot hold their breath for 5 seconds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Application of transthoracic shear-wave ultrasound elastography in pleural lesions
Time frame: six months
to provide the information of tissue elasticity in different etiologies of pleural lesions and to validate the predictive value of shear-wave elastography in differentiating benign pleural lesions from malignant lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
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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.
Yao-Wen Kuo, MD principal investigator
National Taiwan University Hospital
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 Elasticity Imaging Techniques, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 20 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao-Wen Kuo, MD (0972-651-821, kyw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Application of transthoracic shear-wave ultrasound elastography in pleural lesions (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2024.