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

Three-dimensional Ultrasonic Construct on Volumetric Assessment of Lung Disease and Its Clinical Application

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Ultrasound; Lung Cancer (Diagnosis); Peripheral Lung Lesions; Ultrasound Assessment

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: YEN-LIN CHEN, Doctor of Medicine; Phone Number: 262905 +886-2312-3456; Email: moich.chen@gmail.com
• Study Contact Backup: Name: YAO-WEN KUO, Ph.D

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
    • Principal Investigator: YEN-LIN CHEN, Doctor of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ultrasound work-up; participants with peripheral lesions, not confined to lung, referred for ultrasound workup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: YEN-LIN CHEN, Doctor of Medicine, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): February 28, 2031

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lung ultrasound; three-dimensional ultrasound; peripheral lung lesions
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease
• Other Study ID Numbers: 202604005DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data may contain images with unremovable personal information, which may violate the Personal Data Protection Act.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No