ElastographyNCT02636985
Application of Ultrasonic Elastography in Lung Lesions
An observational study of Elastography, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elastography
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- Inclusion Criteria:
Patients with radiographic findings of:
- consolidation
- obstructive pneumonitis
- tumors
- Exclusion Criteria:
- Patients with poor acoustic window
- Unable to hold breathing
- Not cooperative
- Presence of pleural effusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases
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.
Read the detailed description
Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound elastography. The strain ration was measured and was compared between necrosis, atelectasis, consolidation and tumor.
- Conditions
- Elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElastographyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Chien Wang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636985
- Sponsor's protocol ID
- 201503075RINC
- Status last verified
- Dec 2015
- First submitted
- 24 Nov 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27743728
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Ultrasound Elastography in Pulmonary Lesions and Diseases
- ClinicalTrials.gov ID
- NCT02636985
- Acronym / sponsor ID
- 201503075RINC
- Conditions
- Elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients performed conventional B-mode ultrasound, subsequently followed by ultrasound elastography. The strain ration was measured and was compared between necrosis, atelectasis, consolidation and tumor.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of strain ratio between necrosis, atelectasis, consolidation and tumor
Time frame: Up to 15 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
- Derived from this study: PubMed 27743728Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao-Chien Wang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elastography, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of strain ratio between necrosis, atelectasis, consolidation and tumor (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.