NCT02636985

Brief Summary

Elastography is an imaging of tissue elasticity or stiffness and is currently emerging as a mainstream tool for ultrasound-based diagnosis. This compressibility property of materials, mathematically expressed as the change in tissue displacement as a function of its distance from the compressing device, is known as strain and is the parameter that is imaged in an elastogram. Elastography has currently shown promising result in differentiating viscoelastic nature of various organs, which is a consequence of certain underlying diseases. At present, there are limited literatures revealing the application and feasibility of ultrasonic elastography in lung lesions. This is essentially important as it may serve as an adjuvant to B-mode ultrasound. The investigators aimed at exploring the application and feasibility of ultrasonic elastography on lung lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

November 24, 2015

Last Update Submit

December 17, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of strain ratio between necrosis, atelectasis, consolidation and tumor

    The strain ratio was measured under ultrasonic elastography. At least three measurements were performed each time and we average all the measurements as the final strain ratio. Independent t test was used for comparison.

    Up to 15 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with radiographic findings of consolidation, obstructive pneumonitis or tumors, detected on chest computed tomography (CT), who received ultrasound study with or without ultrasound-guided biopsy for tissue proof and UE, from December 2011 to March 2013.

You may qualify if:

  • Patients with radiographic findings of:
  • consolidation
  • obstructive pneumonitis
  • tumors

You may not qualify if:

  • Patients with poor acoustic window
  • Unable to hold breathing
  • Not cooperative
  • Presence of pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei City, 100, Taiwan

Location

Related Publications (1)

  • Lim CK, Chung CL, Lin YT, Chang CH, Lai YC, Wang HC, Yu CJ. Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases. Ultrasound Med Biol. 2017 Jan;43(1):145-152. doi: 10.1016/j.ultrasmedbio.2016.08.028. Epub 2016 Oct 12.

Study Officials

  • Hao-Chien Wang, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 22, 2015

Study Start

December 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations