Lung TumorNCT03881410
The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor
A study testing different types of ultrasound technique in people with Lung Tumor, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor 1. To identify the intra-tumor heterogeneity of elasticity 2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Tumor
- What is being tested?
- different types of ultrasound technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2019to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Patients with radiographic evidence of pulmonary lesions
Who cannot join
- Age < 20 y/o
- Patients who cannot hold their breath for 5 seconds
- Inadequate shear-wave propagation of lung tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor
- To identify the intra-tumor heterogeneity of elasticity
- To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor
- Conditions
- Lung Tumor
- Being tested
- different types of ultrasound technique
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of ultrasound techniqueProcedure or surgery
Shear-wave elastography-guided or Convention ultrasound-guided
| Study group | Role | What they receive |
|---|---|---|
| Shear-wave elastography-guided | Experimental | Shear-wave elastography-guided bipsy Receives: Procedure: different types of ultrasound technique |
| Convention ultrasound-guided | Active comparator | Convention ultrasound-guided biopsy Receives: Procedure: different types of ultrasound technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic yield between two groups
sensitivity, specificity, positive predictive value, and negative predictive value
Measured: 6 months
Secondary outcomes (3)
Total times of the biopsy
Total times of the biopsy
Measured: 1 day
Procedure duration
Time duration
Measured: 1 day
Complication rate
Complications like pneumothorax or hemothorax
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start15 May 2019
- Primary completion2 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TumorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yao-Wen Kuo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881410
- Sponsor's protocol ID
- 201812180RINA
- Status last verified
- Jul 2023
- First submitted
- 15 Mar 2019
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be available upon reasonable request. Additionally, the study protocol, statistical analysis plan, Stata code, and informed consent forms will be shared. Data access will begin three months after publication and remain available for five years. Researchers with methodologically sound proposals may access the data to achieve aims in the approved proposal. Requests for access should be directed to kyw@ntu.edu.tw, and requestors will be required to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03881410
- Acronym / sponsor ID
- 201812180RINA
- Conditions
- Lung Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Mar 2019 (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.
To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor
- To identify the intra-tumor heterogeneity of elasticity
- To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shear-wave elastography-guided | Experimental | Procedure: different types of ultrasound techniqueShear-wave elastography-guided bipsy |
| Convention ultrasound-guided | Active comparator | Procedure: different types of ultrasound techniqueConvention ultrasound-guided biopsy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with radiographic evidence of pulmonary lesions
Key exclusion criteria (3 listed)
- Age < 20 y/o
- Patients who cannot hold their breath for 5 seconds
- Inadequate shear-wave propagation of lung tumor
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 |
|---|---|---|
| different types of ultrasound techniqueShear-wave elastography-guided or Convention ultrasound-guided | Procedure or surgery | Convention ultrasound-guided, Shear-wave elastography-guided |
Primary outcome
The diagnostic yield between two groups
Time frame: 6 months
sensitivity, specificity, positive predictive value, and negative predictive value
3 secondary outcomes
Total times of the biopsy
Time frame: 1 day
Procedure duration
Time frame: 1 day
Complication rate
Time frame: 1 day
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 27 Nov 2024.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) that underlie the results reported in this article, including data dictionaries, will be available upon reasonable request. Additionally, the study protocol, statistical analysis plan, Stata code, and informed consent forms will be shared. Data access will begin three months after publication and remain available for five years. Researchers with methodologically sound proposals may access the data to achieve aims in the approved proposal. Requests for access should be directed to kyw@ntu.edu.tw, and requestors will be required to sign a data access agreement.
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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 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?
A study testing different types of ultrasound technique in people with Lung Tumor, 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 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 27 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?
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?
The diagnostic yield between two groups (time frame: 6 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 27 Nov 2024.