Pulmonary LesionsNCT02146131
Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) (P00029233 )
A study testing Standard FB with fluoroscopy and R-EBUS with ultrathin bronchoscope in people with Pulmonary Lesions and Pulmonary Nodules, run by Medical University of South Carolina at 5 sites in United States.
Trial summary
The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass
- What is being tested?
- Standard FB with fluoroscopy and R-EBUS with ultrathin bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2014to 14 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR
- Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy.
- Are at least 22 years old,
- Lack Bleeding disorders, and
- Are able to provide informed consent
Who cannot join
- Patients with a pure ground-glass opacity identified on chest CT
- Patients with endobronchial involvement seen on chest CT.
- Patients who refuse to participate,
- Are less than 22 years of age,
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
- Are unable to provide informed consent
- Pregnant
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland
Medical University of South Carolina
Charleston, South Carolina, 29425-6300
University of Florida
Gainesville, Florida
Washington University Saint Louis
St Louis, Missouri
Medstar Washington Hospital Center
Washington D.C., District of Columbia
About this study
Official title: Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions
The purpose of this study is to compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.
This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.
- Conditions
- Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass
- Being tested
- Standard FB with fluoroscopy, R-EBUS with ultrathin bronchoscope
- Keywords
- Peripheral pulmonary lesions, Solitary pulmonary lesions, Multiple pulmonary lesions
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard FB with fluoroscopyDevice
Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
R-EBUS with ultrathin bronchoscopeDevice
Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions
| Study group | Role | What they receive |
|---|---|---|
| Standard FB with fluoroscopy | Active comparator | Administration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX). Receives: Device: Standard FB with fluoroscopy |
| R-EBUS with ultrathin bronchoscope | Active comparator | Administration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe.
Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX. Receives: Device: R-EBUS with ultrathin bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJul 2014
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary LesionsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus, Johns Hopkins University, Medstar Health Research Institute, Mayo Clinic, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Nichole T Tanner, MD, M.S.C.R, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146131
- Sponsor's protocol ID
- 00029233
- Status last verified
- Aug 2018
- First submitted
- 20 May 2014
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized Trial of Bronchoscopy With Ultrathin Bronchoscope and Radial Endobronchial Ultrasound (R-EBUS) With Fluoroscopy Versus Standard Fiberoptic Bronchoscopy (FB) With Fluoroscopy for Biopsy of Pulmonary Lesions
- ClinicalTrials.gov ID
- NCT02146131
- Acronym / sponsor ID
- 00029233
- Conditions
- Pulmonary Lesions, Pulmonary Nodules, Pulmonary Mass
- Keywords
- Peripheral pulmonary lesions, Solitary pulmonary lesions, Multiple pulmonary lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Olympus, Johns Hopkins University, Medstar Health Research Institute, Mayo Clinic, Washington University School of Medicine
- Study start
- Jul 2014
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 25 Sep 2018
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 compare the yield of two methods for obtaining a lung tissue sample: Procedure #1: standard fiberoptic bronchoscopy (FB) with fluoroscopy, and Procedure #2: ultrathin bronchoscope procedure with fluoroscopy and radial endobronchial ultrasound (R-EBUS). These two procedures are similar in that they both: (1) enable your doctor to look inside your lungs with a device called a bronchoscope, and (2) Use fluoroscopy, which is a technique that uses X-rays to see your lungs.
This will give the doctor an opportunity to use either of the bronchoscopy methods described above and compare the tests to see if R-EBUS provides better results than standard bronchoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard FB with fluoroscopy | Active comparator | Device: Standard FB with fluoroscopyAdministration of moderate or deep sedation, introduction of standard adult bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Localization of the lesion using fluoroscopy followed by the acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Evaluation of acquired samples for pathology. Performance of a portable chest X-ray to look for pneumothorax (PTX). |
| R-EBUS with ultrathin bronchoscope | Active comparator | Device: R-EBUS with ultrathin bronchoscopeAdministration of moderate or deep sedation, introduction of ultrathin bronchoscope into the airway. Following application of topical anesthesia on vocal cord, trachea, bronchoscope is advanced distally under direct visualization. Attempt to definitively locate the lesion with mechanical R-EBUS probe. Acquisition of pathologic and cytologic specimens using standard bronchial brush and standard transbronchial biopsy forceps. Performance of a portable chest X-ray to look for PTX. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a solid lung lesion 2-5cm identified on chest CT with the intention to undergo bronchoscopic evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm.The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. This will include patients determined to have an intermediate risk of malignancy (5-65%) and those non-surgical candidate with higher risk lesions in need of diagnosis for alternative treatment. OR
- Patients with a solid lung lesion 2-5cm identified on chest CT that are surgical candidates with a high probability of cancer (>65%) will be referred for surgical evaluation. If the lesion is partially solid (ie there is a ground glass component) then the solid portion must make up >75% of the lesion and measure at 2-5cm. If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study. All sites will use the same online calculator to document probability of malignancy.
- Are at least 22 years old,
- Lack Bleeding disorders, and
- Are able to provide informed consent
Key exclusion criteria (7 listed)
- Patients with a pure ground-glass opacity identified on chest CT
- Patients with endobronchial involvement seen on chest CT.
- Patients who refuse to participate,
- Are less than 22 years of age,
- Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, and
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 |
|---|---|---|
| Standard FB with fluoroscopyTechnique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions | Device | Standard FB with fluoroscopy |
| R-EBUS with ultrathin bronchoscopeTechnique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions | Device | R-EBUS with ultrathin bronchoscope |
Primary outcome
Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nichole T Tanner, MD, M.S.C.R principal investigator
Medical University of South Carolina
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard FB with fluoroscopy and R-EBUS with ultrathin bronchoscope in people with Pulmonary Lesions and Pulmonary Nodules, run by Medical University of South Carolina at 5 sites in United States.
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 7 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Procedures; Number of Positive Diagnosis of Pulmonary Lesions (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months). 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 25 Sep 2018.