Lung CancerNCT01077492
Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study
An observational study of Lung Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Virtual Bronchoscopy Navigation
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.
Who may be able to join
- Age > 18 years
- Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings
- Suspected involvement of mediastinal lymph nodes on CT-PET scan
- Written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer
The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.
Read the detailed description
Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.
- Conditions
- Lung Cancer
- Being tested
- Virtual Bronchoscopy Navigation
- Keywords
- lung cancer, mediastinal lymph nodes, TBNA, staging lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Bronchoscopy NavigationOther
Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.
| Study group | Role | What they receive |
|---|---|---|
| Suspected mediastianl lymph nodes | Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines. Receives: Other: Virtual Bronchoscopy Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of VB in determining N2/N3 mediastinal lymph nodes
Feasibility of virtual bronchoscopy in showing the presence or abscense of N2/N3 mediastinal lymph node (MLN) metastasis with accuracy of 0.6 in puncturing MLN > 15 mm (CT images) and accuracy of 0.8 for MLN < 15 mm in the second phase of the study.
Measured: 1 year
Secondary outcomes (1)
Duration of the session within the optimal time window of local anesthesia using lidocaine 1%; comparable to standard routine bronchoscopic procedure on an outpatient basis, i.e. not exceeding 30 minutes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Investigators
- Sayed Hashemi, MD, Study chair, Amsterdam UMC, location VUmcHans Daniels, MD, Study chair, Amsterdam UMC, location VUmcEmiel Comans, PhD, Study chair, Amsterdam UMC, location VUmcOtto Hoekstra, PhD, Study chair, Amsterdam UMC, location VUmcPiet Postmus, PhD, Study chair, Amsterdam UMC, location VUmcTom Sutedja, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077492
- Sponsor's protocol ID
- 09/327
- Status last verified
- Feb 2010
- First submitted
- 26 Feb 2010
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer
- ClinicalTrials.gov ID
- NCT01077492
- Acronym / sponsor ID
- 09/327
- Conditions
- Lung Cancer
- Keywords
- lung cancer, mediastinal lymph nodes, TBNA, staging lung cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Mar 2010 (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 purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.
Detailed description
Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected mediastianl lymph nodes | – | Other: Virtual Bronchoscopy NavigationPatients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.
Key inclusion criteria (4 listed)
- Age > 18 years
- Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings
- Suspected involvement of mediastinal lymph nodes on CT-PET scan
- Written informed consent
Key exclusion criteria (1 listed)
- None
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 NavigationUse of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data. | Other | Suspected mediastianl lymph nodes |
Primary outcome
Feasibility of VB in determining N2/N3 mediastinal lymph nodes
Time frame: 1 year
Feasibility of virtual bronchoscopy in showing the presence or abscense of N2/N3 mediastinal lymph node (MLN) metastasis with accuracy of 0.6 in puncturing MLN > 15 mm (CT images) and accuracy of 0.8 for MLN < 15 mm in the second phase of the study.
1 secondary outcome
Duration of the session within the optimal time window of local anesthesia using lidocaine 1%; comparable to standard routine bronchoscopic procedure on an outpatient basis, i.e. not exceeding 30 minutes.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
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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.
Sayed Hashemi, MD study chair
Amsterdam UMC, location VUmc
Hans Daniels, MD study chair
Amsterdam UMC, location VUmc
Emiel Comans, PhD study chair
Amsterdam UMC, location VUmc
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 Lung Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 2 Nov 2012. 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 Netherlands. 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 was stopped early. 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?
Feasibility of VB in determining N2/N3 mediastinal lymph nodes (time frame: 1 year). 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 2 Nov 2012.