3D-US Construct on Volumetric Assessment of Lung Disease... | NCT07574255

Studies
3D-US Construct on Volumetric Assessment of Lung Disease & Clinical Application

NCT07574255

Sponsor

National Taiwan University Hospital

Status

Not yet recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Lung Ultrasound
Lung Cancer (Diagnosis)
Peripheral Lung Lesions
Ultrasound Assessment

Interventions

Not provided

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

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2026Estimated

Primary Completion Date

Feb 28, 2031Estimated

Completion Date

Feb 28, 2031Estimated

First Submitted Date

May 3, 2026

First Submission Date that Met QC Criteria

May 3, 2026

First Posted Date

May 7, 2026Actual

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

May 3, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The goal of this observational study is to establish the three-dimensional construct of lung lesion via ultrasound in patients with peripheral lung lesions or any superficial lesion in thoracic fields. The primary question our study aims to answer is:

Whether the 3D ultrasound morphology can reflect lung disease entities? Whether the 3D volumetric follow-up protocol can be standardised to reflect lung disease status?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ultrasound work-up		participants with peripheral lesions, not confined to lung, referred for ultrasound workup

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
volume of measured lesion	Standard volume will be defined by computed tomography measurement, and the ultrasound 3D-volmetric result would be compared	from enrollment, every 6 weeks until 24th week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants suspect with lung lesions referred for ultrasound workup

Exclusion Criteria:

Participants aged < 18 years
Participants refusal
Participants with implanted metal in scanning area interfering data collection
Participants who cannot perform breath holding for at least 1 second

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with peripheral lung lesions or with lesions located at superficial thoracic field will be recruited from referral cases for ultrasound workup

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YEN-LIN CHEN, Doctor of Medicine	Contact	+886-2312-3456	262905	moich.chen@gmail.com
YAO-WEN KUO, Ph.D	Contact

Overall Officials

Name	Affiliation	Role
YEN-LIN CHEN, Doctor of Medicine	National Taiwan University Hospital	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual data may contain images with unremovable personal information, which may violate the Personal Data Protection Act.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D004194	Disease

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