The Efficacy of Shear-wave Elastography-guided Aspiration... | NCT03881410

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

NCT03881410

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

413Actual

Phase

Not Applicable

Conditions

Lung Tumor

Interventions

different types of ultrasound technique

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2019Actual

Primary Completion Date

Dec 2, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Mar 15, 2019

First Submission Date that Met QC Criteria

Mar 17, 2019

First Posted Date

Mar 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

413Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shear-wave elastography-guided	Experimental	Shear-wave elastography-guided bipsy	Procedure: different types of ultrasound technique
Convention ultrasound-guided	Active Comparator	Convention ultrasound-guided biopsy	Procedure: different types of ultrasound technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
different types of ultrasound technique	Procedure	Shear-wave elastography-guided or Convention ultrasound-guided	Convention ultrasound-guided Shear-wave elastography-guided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic yield between two groups	sensitivity, specificity, positive predictive value, and negative predictive value	6 months

Secondary Outcomes

Measure	Description	Time Frame
Total times of the biopsy	Total times of the biopsy	1 day
Procedure duration	Time duration	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

(1) Patients with radiographic evidence of pulmonary lesions

Exclusion criteria:

Age < 20 y/o
Patients who cannot hold their breath for 5 seconds
Inadequate shear-wave propagation of lung tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yao-Wen Kuo	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided