Thoracic LesionsNCT02755506
Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
A study testing endobronchial ultrasound elastography in people with Thoracic Lesions, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracic Lesions
- What is being tested?
- endobronchial ultrasound elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2016
- Phase
- Interventional
- 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
Who may be able to join
- Hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( CT) scan and/or positron emission tomography-computed tomography (PET-CT)
- With normal Coagulation function
- With normal cardio pulmonary function and be able to tolerate bronchoscopy
- No syphilis,acquired immune deficiency syndrome(AIDS) and other infectious diseases
- Willing and able to give written informed consent
Who cannot join
- Unable to lie in bed
- Allergy to narcotics such as lidocaine.
- Suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal.
- With abnormal Coagulation function or take anticoagulant drugs within the previous week.
- Hematological abnormalities, fever or highly suspected active tuberculosis patients.
- Women in the menstrual period.
- Excessive anxiety and can not tolerate bronchoscopy.
- Other conditions that are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions
Read the detailed description
Ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.The aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions.
Conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. Features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. The investigators define the pathological results of EBUS-TBNA combined with results of six months follow-up as the "Gold Standard". The receiver operator characteristic curves are drawn to obtain area under the Curve (AUC) and the best diagnostic threshold values of each parameters. According to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography
- Conditions
- Thoracic Lesions
- Being tested
- endobronchial ultrasound elastography
- Keywords
- Ultrasound elastography, Thoracic lesions, EBUS-TBNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial ultrasound elastographyDevice
Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography
| Study group | Role | What they receive |
|---|---|---|
| patients with thoracic lesions | Experimental | Patients with thoracic lesions is going to undergo endobronchial ultrasound elastography followed by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Receives: Device: endobronchial ultrasound elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography strain ratio
Elastography strain ratios were calculated between selected area of the lesions and the surrounding normal tissues.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of strain ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Measured: six months
Elasticity score
Elasticity scores were obtained by analyzing elastography images.Scores:1-2: benign;3-4: malignant lesions. The sensitivity and specificity of elastography for the diagnosis of malignant thoracic lesions were calculated on the basis of above-specified criteria. The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Measured: six months
Elastography area ratio
Elastography area ratios were defined as following:areas as blue pixels/lesion areas as region of interest pixels.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of area ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Measured: six months
Secondary outcomes (1)
Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic LesionsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liang-an Chen, MD,PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755506
- Sponsor's protocol ID
- S2016-020-01
- Status last verified
- Apr 2016
- First submitted
- 15 Apr 2016
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
- ClinicalTrials.gov ID
- NCT02755506
- Acronym / sponsor ID
- S2016-020-01
- Conditions
- Thoracic Lesions
- Keywords
- Ultrasound elastography, Thoracic lesions, EBUS-TBNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 29 Apr 2016 (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.
The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions
Detailed description
Ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.The aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions.
Conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. Features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. The investigators define the pathological results of EBUS-TBNA combined with results of six months follow-up as the "Gold Standard". The receiver operator characteristic curves are drawn to obtain area under the Curve (AUC) and the best diagnostic threshold values of each parameters. According to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with thoracic lesions | Experimental | Device: endobronchial ultrasound elastographyPatients with thoracic lesions is going to undergo endobronchial ultrasound elastography followed by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( CT) scan and/or positron emission tomography-computed tomography (PET-CT)
- With normal Coagulation function
- With normal cardio pulmonary function and be able to tolerate bronchoscopy
- No syphilis,acquired immune deficiency syndrome(AIDS) and other infectious diseases
- Willing and able to give written informed consent
Key exclusion criteria (8 listed)
- Unable to lie in bed
- Allergy to narcotics such as lidocaine.
- Suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal.
- With abnormal Coagulation function or take anticoagulant drugs within the previous week.
- Hematological abnormalities, fever or highly suspected active tuberculosis patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endobronchial ultrasound elastographyBefore endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography | Device | patients with thoracic lesions |
Primary outcome
Elastography strain ratio
Time frame: six months
Elastography strain ratios were calculated between selected area of the lesions and the surrounding normal tissues.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of strain ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Elasticity score
Time frame: six months
Elasticity scores were obtained by analyzing elastography images.Scores:1-2: benign;3-4: malignant lesions. The sensitivity and specificity of elastography for the diagnosis of malignant thoracic lesions were calculated on the basis of above-specified criteria. The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Elastography area ratio
Time frame: six months
Elastography area ratios were defined as following:areas as blue pixels/lesion areas as region of interest pixels.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of area ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
1 secondary outcome
Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No. Because of personal privacy, the research-related individual participant data do not intend for public sharing.
Related trials for Thoracic Lesions
RecruitingPhase 3
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Not yet recruiting
A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
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.
Liang-an Chen, MD,PhD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endobronchial ultrasound elastography in people with Thoracic Lesions, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 29 Apr 2016. 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 China. 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?
Results are not available in the source record.
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?
Elastography strain ratio (time frame: six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2016.