The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor
1 other identifier
interventional
413
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2019
CompletedFirst Posted
Study publicly available on registry
March 19, 2019
CompletedStudy Start
First participant enrolled
May 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 27, 2024
July 1, 2023
4.6 years
March 15, 2019
November 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The diagnostic yield between two groups
sensitivity, specificity, positive predictive value, and negative predictive value
6 months
Secondary Outcomes (3)
Total times of the biopsy
1 day
Procedure duration
1 day
Complication rate
1 day
Study Arms (2)
Shear-wave elastography-guided
EXPERIMENTALShear-wave elastography-guided bipsy
Convention ultrasound-guided
ACTIVE COMPARATORConvention ultrasound-guided biopsy
Interventions
Shear-wave elastography-guided or Convention ultrasound-guided
Eligibility Criteria
You may qualify if:
- (1) Patients with radiographic evidence of pulmonary lesions
You may not qualify if:
- Age \< 20 y/o
- Patients who cannot hold their breath for 5 seconds
- Inadequate shear-wave propagation of lung tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao-Wen Kuo
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2019
First Posted
March 19, 2019
Study Start
May 15, 2019
Primary Completion
December 2, 2023
Study Completion
December 31, 2023
Last Updated
November 27, 2024
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data access will begin three months after publication and remain available for five years.
- Access Criteria
- Researchers with methodologically sound proposals may access the data to achieve aims in the approved proposal.
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.