Solitary Pulmonary NodulePhase 2NCT00925210
Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach
A Phase 2 study testing Sequential pEBUS - ENB in people with Solitary Pulmonary Nodule and Lung Cancer, run by University of Calgary at 2 sites in Canada.
Trial summary
Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Solitary Pulmonary Nodule, Lung Cancer
- What is being tested?
- Sequential pEBUS - ENB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2009to Sep 2010
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >16 years
- Lung nodule (s) identified on CT scan
- Clinical decision to obtain tissue biopsy of lung lesion
- CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)
- Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic
Who cannot join
- Lack of informed consent
- Nodule less than 1 cm or greater than 6 cm long axis
- Mediastinal adenopathy >2cm short axis on CT chest
- Evidence of endobronchial abnormality on chest CT
- Medical contraindication to bronchoscopy
- Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.
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- Patient with implanted electronic medical device
- Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy)
- Confirmed or suspected pregnancy
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foothills Medical Center
Calgary, Alberta, T2N4N1
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V4G5
About this study
Official title: Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).
- Conditions
- Solitary Pulmonary Nodule, Lung Cancer
- Being tested
- Sequential pEBUS - ENB
- Keywords
- Endobronchial ultrasound, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Ultrasonography
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential pEBUS - ENBProcedure or surgery
Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected.
If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected.
| Study group | Role | What they receive |
|---|---|---|
| Sequential pEBUS - ENB | Experimental | Not described Receives: Procedure: Sequential pEBUS - ENB |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic yield
Secondary outcomes (4)
sensitivity, specificity, positive and negative predictive value
Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
Complication rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solitary Pulmonary NoduleStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925210
- Sponsor's protocol ID
- 22176
- Status last verified
- Sep 2010
- First submitted
- 18 Jun 2009
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
- ClinicalTrials.gov ID
- NCT00925210
- Acronym / sponsor ID
- 22176
- Conditions
- Solitary Pulmonary Nodule, Lung Cancer
- Keywords
- Endobronchial ultrasound, Electromagnetic Navigation Bronchoscopy, Bronchoscopy, Ultrasonography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Jun 2009 (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.
Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential pEBUS - ENB | Experimental | Procedure: Sequential pEBUS - ENB |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age >16 years
- Lung nodule (s) identified on CT scan
- Clinical decision to obtain tissue biopsy of lung lesion
- CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)
- Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic
Key exclusion criteria (9 listed)
- Lack of informed consent
- Nodule less than 1 cm or greater than 6 cm long axis
- Mediastinal adenopathy >2cm short axis on CT chest
- Evidence of endobronchial abnormality on chest CT
- Medical contraindication to bronchoscopy
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 |
|---|---|---|
| Sequential pEBUS - ENBSubject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected. If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected. | Procedure or surgery | Sequential pEBUS - ENB |
Primary outcome
diagnostic yield
4 secondary outcomes
sensitivity, specificity, positive and negative predictive value
Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
Complication rate
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 14 Sep 2010.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sequential pEBUS - ENB in people with Solitary Pulmonary Nodule and Lung Cancer, run by University of Calgary at 2 sites in Canada.
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 9 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: finished, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
diagnostic yield. 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 14 Sep 2010.