The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor

Lung Tumor Clinical Trial

Official title:

The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03881410
• Other study ID #: 201812180RINA
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

1. Age < 20 y/o

2. Patients who cannot hold their breath for 5 seconds

3. Inadequate shear-wave propagation of lung tumor

Related Conditions & MeSH terms

• Lung Neoplasms
• Lung Tumor

Intervention

Procedure:
• different types of ultrasound technique
Shear-wave elastography-guided or Convention ultrasound-guided

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The diagnostic yield between two groups	sensitivity, specificity, positive predictive value, and negative predictive value	6 months
Secondary	Total times of the biopsy	Total times of the biopsy	1 day
Secondary	Procedure duration	Time duration	1 day
Secondary	Complication rate	Complications like pneumothorax or hemothorax	1 day