Elasticity Imaging TechniquesNCT03376425
Transthoracic Shear-wave Ultrasound Elastography
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 pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary lesions from malignant lesions. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Elasticity Imaging Techniques
- How many people
- 2,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Dec 2017to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving chest ultrasonography in National Taiwan University Hospital
- Inclusion criteria: (1) Retrospective cohort from Jan 2016 to Dec 2017 (2) Patients with radiographic evidence of pulmonary tumors
- Exclusion criteria: (1) age < 20 y/o (2) patients who can't hold their breath for 5 seconds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yao-Wen Kuo, MD, 0972-651-821, kyw@ntu.edu.tw
About this study
Official title: Application of Transthoracic Shear-wave Ultrasound Elastography in the Diagnosis of Pulmonary Lesions
This study aims to provide the information of tissue elasticity in different etiologies of pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary lesions from malignant lesions.
- Conditions
- Elasticity Imaging Techniques
- Keywords
- Chest ultrasound,Lung tumor
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 the Diagnosis of Pulmonary Lesions
to provide the information of tissue elasticity in different etiologies of pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary 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 posted18 Dec 2017
- Study start8 Dec 2017
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,000 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
- NCT03376425
- Sponsor's protocol ID
- 201709073RINB
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2017
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuo YW, Chen YL, Wu HD, Chien YC, Huang CK, Wang HC. Application of transthoracic shear-wave ultrasound elastography in lung lesions. Eur Respir J. 2021 Mar 25;57(3):2002347. doi: 10.1183/13993003.02347-2020. Print 2021 Mar.
PubMed 33033150
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transthoracic Shear-wave Ultrasound Elastography in the Diagnosis of Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT03376425
- Acronym / sponsor ID
- 201709073RINB
- Conditions
- Elasticity Imaging Techniques
- Keywords
- Chest ultrasound,Lung tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Dec 2017 (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 pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary lesions from malignant lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving chest ultrasonography in National Taiwan University Hospital
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 the Diagnosis of Pulmonary Lesions
Time frame: six months
to provide the information of tissue elasticity in different etiologies of pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary lesions from malignant lesions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 33033150Kuo YW, Chen YL, Wu HD, Chien YC, Huang CK, Wang HC. Application of transthoracic shear-wave ultrasound elastography in lung lesions. Eur Respir J. 2021 Mar 25;57(3):2002347. doi: 10.1183/13993003.02347-2020. Print 2021 Mar.
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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.
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?
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: looking for participants now, as of the sponsor's last update on 18 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao-Wen Kuo (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 the Diagnosis of Pulmonary 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?
On the ClinicalTrials.gov record for NCT03376425, which also lists 1 linked publication.
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 18 Nov 2024.