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Bronchoscopy Techniques with/without ROSE for Lung Cancer

N/A
Waitlist Available
Led By Alain Tremblay, MDCM
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of a peripheral pulmonary lesion (PPL) of ≤5cm (mean short-long on axial CT) suspicious for malignancy.
Adults ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months up to 1 year
Awards & highlights

Study Summary

This trial is investigating whether two different techniques for investigating pulmonary nodules (small growths) in the lungs are better than each other. One technique uses a regular bronchoscope (a thin, tube-like instrument used to look at the inside of the lungs), while the other uses a "slim" bronchoscope. The trial will also look at whether using a cytopathologist (a doctor who specializes in diagnosing diseases by looking at cells) to evaluate the specimens in real-time is better than not using one.

Who is the study for?
Adults over 18 with a lung lesion suspicious for cancer, accessible via pEBUS, and no major lymph node involvement on scans. They've chosen to undergo bronchoscopy after discussing with their doctor.Check my eligibility
What is being tested?
The study compares two ways of sampling lung lesions: using rapid on-site evaluation (ROSE) or not, and using a slim or standard bronchoscope. It's designed to see which method is better at diagnosing lung issues.See study design
What are the potential side effects?
Potential side effects may include discomfort from the bronchoscope procedure, bleeding where the tissue sample is taken, infection risk, and possible complications related to sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a lung spot smaller than 5cm that may be cancer.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peripheral pulmonary lesion diagnostic yield
Secondary outcome measures
Complications
Extra diagnostic procedure required for final diagnosis.
Sample adequacy for adjunctive testing if lung cancer
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: ROSE without guide sheathExperimental Treatment2 Interventions
Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.
Group II: ROSE with guide sheathExperimental Treatment1 Intervention
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE
Group III: No guide sheath without ROSEExperimental Treatment1 Intervention
Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE.
Group IV: Guide sheath without ROSEExperimental Treatment1 Intervention
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapid on-site evaluation (ROSE)
2018
N/A
~800

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,548 Total Patients Enrolled
McGill UniversityOTHER
394 Previous Clinical Trials
998,195 Total Patients Enrolled
Laval UniversityOTHER
417 Previous Clinical Trials
172,086 Total Patients Enrolled

Media Library

Slim bronchoscope without a guide sheath Clinical Trial Eligibility Overview. Trial Name: NCT03809169 — N/A
Lung Cancer Research Study Groups: ROSE with guide sheath, ROSE without guide sheath, Guide sheath without ROSE, No guide sheath without ROSE
Lung Cancer Clinical Trial 2023: Slim bronchoscope without a guide sheath Highlights & Side Effects. Trial Name: NCT03809169 — N/A
Slim bronchoscope without a guide sheath 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809169 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath
2019. "Peripheral EBUS With ROSE vs no ROSE; Slim Bronchoscope Without Guide Sheath vs Standard Bronchoscope With Guide Sheath". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03809169.
~34 spots leftby Apr 2025
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