Peripheral Lung LesionsPhase 1NCT03536026
Localization of Peripheral Pulmonary Lesions: A Pilot Study
A Phase 1 study testing Conventional bronchoscopy, VIDA Pulmonary Workstation 2 and Biopsy in people with Peripheral Lung Lesions, run by Washington University School of Medicine.
Trial summary
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Lung Lesions
- What is being tested?
- Conventional bronchoscopy, VIDA Pulmonary Workstation 2 and Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2018to 1 Nov 2018
- Phase
- Phase 1
- 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
- Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
- Are at least 18 years old
- Are able to provide informed consent
- Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
Who cannot join
- Patients who refuse to participate
- Are less than 18 years of age
- Are pregnant
- Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
- Are unable to provide informed consent
About this study
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.
- Conditions
- Peripheral Lung Lesions
- Being tested
- Conventional bronchoscopy, VIDA Pulmonary Workstation 2, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional bronchoscopyProcedure or surgery
-Standard of care
VIDA Pulmonary Workstation 2Device
-Virtual bronchoscopic navigation system
BiopsyProcedure or surgery
-Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Bronchoscopic evaluation and biopsy | Experimental | -Bronchoscopy will be performed by pulmonary and/or critical care fellows who have performed fewer than 10 bronchoscopies (inexperienced bronchoscopists) under direct supervision by an attending Interventional Pulmonologist. The inexperienced bronchoscopist will attempt to navigate to the targeted peripheral pulmonary lesion without virtual bronchoscopic navigation, using only standard axial CT images as a reference. The attending physician will directly observe, but will provide no guidance during this period, which will last no longer than 10 minutes. If the lesion is located and confirmed with radial probe endobronchial ultrasound prior to 10 minutes, biopsies will be performed as per routine clinical practice. If the 10 minute time period elapses prior to localization of the peripheral pulmonary lesion, virtual bronchoscopic navigation will be used. Receives: Procedure: Conventional bronchoscopy; Device: VIDA Pulmonary Workstation 2; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound
Measured: At the time of bronchoscopy (day 1)
Secondary outcomes (4)
Rate of lesion localization using a conventional chest CT as a reference only
Measured: At the time of bronchoscopy (day 1)
Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only)
Measured: At the time of bronchoscopy (day 1)
Time to localization of peripheral pulmonary lesions
Measured: At the time of bronchoscopy (day 1)
Diagnostic yield of procedures
-Diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive.
Measured: At the time of bronchoscopy (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start30 Apr 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Why it stopped: Was unable to enroll any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Lung LesionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Chen, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536026
- Sponsor's protocol ID
- 201711034
- Status last verified
- Dec 2018
- First submitted
- 14 May 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Peripheral Pulmonary Lesions: A Pilot Study
- ClinicalTrials.gov ID
- NCT03536026
- Acronym / sponsor ID
- 201711034
- Conditions
- Peripheral Lung Lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Was unable to enroll any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 24 May 2018 (actual)
- 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.
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchoscopic evaluation and biopsy | Experimental | Procedure: Conventional bronchoscopy, Device: VIDA Pulmonary Workstation 2, Procedure: Biopsy-Bronchoscopy will be performed by pulmonary and/or critical care fellows who have performed fewer than 10 bronchoscopies (inexperienced bronchoscopists) under direct supervision by an attending Interventional Pulmonologist. The inexperienced bronchoscopist will attempt to navigate to the targeted peripheral pulmonary lesion without virtual bronchoscopic navigation, using only standard axial CT images as a reference. The attending physician will directly observe, but will provide no guidance during this period, which will last no longer than 10 minutes. If the lesion is located and confirmed with radial probe endobronchial ultrasound prior to 10 minutes, biopsies will be performed as per routine clinical practice. If the 10 minute time period elapses prior to localization of the peripheral pulmonary lesion, virtual bronchoscopic navigation will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
- Are at least 18 years old
- Are able to provide informed consent
- Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
Key exclusion criteria (5 listed)
- Patients who refuse to participate
- Are less than 18 years of age
- Are pregnant
- Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
- Are unable to provide informed consent
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 |
|---|---|---|
| Conventional bronchoscopy-Standard of care | Procedure or surgery | Bronchoscopic evaluation and biopsy |
| VIDA Pulmonary Workstation 2-Virtual bronchoscopic navigation system | Device | Bronchoscopic evaluation and biopsy |
| Biopsy-Standard of care | Procedure or surgery | Bronchoscopic evaluation and biopsy |
Primary outcome
Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound
Time frame: At the time of bronchoscopy (day 1)
4 secondary outcomes
Rate of lesion localization using a conventional chest CT as a reference only
Time frame: At the time of bronchoscopy (day 1)
Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only)
Time frame: At the time of bronchoscopy (day 1)
Time to localization of peripheral pulmonary lesions
Time frame: At the time of bronchoscopy (day 1)
Diagnostic yield of procedures
Time frame: At the time of bronchoscopy (day 1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alexander Chen, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conventional bronchoscopy, VIDA Pulmonary Workstation 2 and Biopsy in people with Peripheral Lung Lesions, run by Washington University School of Medicine.
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 5 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: withdrawn, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound (time frame: At the time of bronchoscopy (day 1)). 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 20 Dec 2018.