Lung Cancer,VB/EBUS-TBNANCT01784185
Virtual Bronchoscopy (VB) vs. Endobronchial Ultrasound (EBUS) Guided Mediastinal Sampling
A study testing virtual bronchoscopy guided transbronchial needle aspiration and endobronchial ultrasound guided transbronchial needle aspiration in people with Lung Cancer, and Mediastinal Tumors,, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer,, Mediastinal Tumors,, Lymphomas,
- What is being tested?
- virtual bronchoscopy guided transbronchial needle aspiration and endobronchial ultrasound guided transbronchial needle aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2013to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provided informed consent
- mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling
- quality of the CT scan which allows bronchial tree and mediastinal target segmentation and reconstruction
Who cannot join
- Age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Warsaw, 02-097
Rafal Krenke, MD, PhD, +48225992562, rafalkrenke@interia.pl
Rafal Krenke, MD, PhD
About this study
Official title: Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
The study has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. The software uses data from thorax CT scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. The most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in VB mode.
The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.
- Conditions
- Lung Cancer,, Mediastinal Tumors,, Lymphomas,, Sarcoidosis,
- Being tested
- virtual bronchoscopy guided transbronchial needle aspiration, endobronchial ultrasound guided transbronchial needle aspiration
- Keywords
- EBUS guided transbronchial needle aspiration (EBUS-TBNA), virtual bronchoscopy (VB), VB guided transbronchial needle aspiration VB-TBNA), mediastinal sampling, transbronchial needle aspiration (TBNA)
- Medical subject headings
- Lung Neoplasms, Lymphoma, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual bronchoscopy guided transbronchial needle aspirationProcedure or surgery
Also called VB-TBNA
endobronchial ultrasound guided transbronchial needle aspirationProcedure or surgery
Also called EBUS-TBNA
endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
| Study group | Role | What they receive |
|---|---|---|
| virtual bronchoscopy guided transbronchial needle aspiration | Experimental | virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session Receives: Procedure: virtual bronchoscopy guided transbronchial needle aspiration; Procedure: endobronchial ultrasound guided transbronchial needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
Comparison of the quality and adequacy of the cytologic specimens (in terms of lymphocyte percentage, the presence of neoplastic cells and dust-laden macrophages) collected by VB-TBNA vs. EBUS-TBNA in patients with mediastinal mass or mediastinal lymph node enlargement
Measured: Approximately five days after the procedure, when the results of the cytological examination will be available
Secondary outcomes (1)
Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas)
Comparison of the diagnostic accuracy of VB-TBNA vs. EBUS-TBNA (in terms of number of cytologic specimens containing diagnostic material e.g. neoplastic cells, granulomas) in patients with mediastinal mass or mediastinal lymph node enlargement. Also the number of patients in whom the specific diagnosis could be established by VB-TBNA vs EBUS-TBNA.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer,Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Warsaw University of Technology
- Responsible party
- Principal investigator, Rafał Krenke, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784185
- Sponsor's protocol ID
- IPU-DIMPA-WUM12(1)
- Acronym
- VB/EBUS-TBNA
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2013
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Clinical Utility of Virtual Bronchoscopy (VB)-Based System for Bronchoscopic Navigation, Mediastinal Mapping and Transbronchial Aspiration of Mediastinal Lesions.
- ClinicalTrials.gov ID
- NCT01784185
- Acronym / sponsor ID
- VB/EBUS-TBNA / IPU-DIMPA-WUM12(1)
- Conditions
- Lung Cancer,, Mediastinal Tumors,, Lymphomas,, Sarcoidosis,
- Keywords
- EBUS guided transbronchial needle aspiration (EBUS-TBNA), virtual bronchoscopy (VB), VB guided transbronchial needle aspiration VB-TBNA), mediastinal sampling, transbronchial needle aspiration (TBNA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Warsaw University of Technology
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Feb 2013 (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 has been designed to evaluate the clinical application of the new virtual bronchoscopy (VB) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. The software uses data from thorax CT scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. The most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in VB mode.
The diagnostic yield of the new system-assisted TBNA will be compared to the reference method (EBUS-TBNA). The study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and TBNA can be applied as diagnostic methods. Both, virtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA) and EBUS-TBNA of the mediastinal targets are performed during the same diagnostic bronchoscopy. Cytologic material from VB-TBNA and EBUS-TBNA is evaluated by two independent pathologists blinded to the method used to obtain the sample. Diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual bronchoscopy guided transbronchial needle aspiration | Experimental | Procedure: virtual bronchoscopy guided transbronchial needle aspiration, Procedure: endobronchial ultrasound guided transbronchial needle aspirationvirtual bronchoscopy guided transbronchial needle aspiration (VB-TBNA)(experimental method) and EBUS-TBNA (reference method) are performed in the same diagnostic session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provided informed consent
- mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling
- quality of the CT scan which allows bronchial tree and mediastinal target segmentation and reconstruction
Key exclusion criteria (2 listed)
- Age below 18 years
- known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
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 |
|---|---|---|
| virtual bronchoscopy guided transbronchial needle aspirationAlso: VB-TBNA | Procedure or surgery | virtual bronchoscopy guided transbronchial needle aspiration |
| endobronchial ultrasound guided transbronchial needle aspirationAlso: EBUS-TBNAendobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions | Procedure or surgery | virtual bronchoscopy guided transbronchial needle aspiration |
Primary outcome
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA
Time frame: Approximately five days after the procedure, when the results of the cytological examination will be available
Comparison of the quality and adequacy of the cytologic specimens (in terms of lymphocyte percentage, the presence of neoplastic cells and dust-laden macrophages) collected by VB-TBNA vs. EBUS-TBNA in patients with mediastinal mass or mediastinal lymph node enlargement
1 secondary outcome
Diagnostic accuracy of VB-TBNA vs. EBUS-TBNA - the number (and percentage) of cytologic specimens containing diagnostic material (neoplastic cells, granulomas)
Time frame: up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual bronchoscopy guided transbronchial needle aspiration and endobronchial ultrasound guided transbronchial needle aspiration in people with Lung Cancer, and Mediastinal Tumors,, run by Medical University of Warsaw at 1 site in Poland.
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 3 inclusion and 2 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 13 Jan 2014. 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 Poland. 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?
Contact Rafal Krenke, MD, PhD (+48225992562, rafalkrenke@interia.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of cytologic specimens collected by VB-TBNA vs. EBUS-TBNA (time frame: Approximately five days after the procedure, when the results of the cytological examination will be available). 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 13 Jan 2014.