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Procedure
EBUS-TBNA for Lung Cancer
N/A
Recruiting
Led By Kazuhiro Yasufuku, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status score (WHO/ECOG) of 0-2
Medically inoperable for surgical resection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial reports that a less invasive but effective treatment, stereotactic body radiation therapy (SBRT), is well-tolerated for early stage lung cancer in medically inoperable patients.
Who is the study for?
This trial is for adults over 18 with confirmed non-small cell lung cancer who can't have surgery or chose not to. They should be in fair health (performance status 0-2), have early-stage T1-2 disease without distant metastasis, and need EBUS-TBNA staging before SBRT treatment. Pregnant women, those unfit for bronchoscopy, or planning other treatments are excluded.Check my eligibility
What is being tested?
The trial tests the use of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) for lymph node staging in patients with lung cancer who will undergo Stereotactic Body Radiotherapy (SBRT). It aims to provide a less invasive option for accurate diagnosis and treatment planning.See study design
What are the potential side effects?
While specific side effects aren't listed here, EBUS-TBNA is generally considered minimally invasive with potential risks like minor bleeding, infection risk at the needle site, and discomfort similar to other bronchoscopy procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than 50% of my waking hours.
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I cannot undergo surgery for my condition.
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I am 18 years old or older.
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My cancer is confirmed as non-small cell lung cancer through testing.
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My cancer is in an early stage and hasn't spread far.
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I have chosen not to undergo surgery for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).
Secondary outcome measures
The treatment outcome (nodal recurrence rate) will be evaluated based on clinical chart review.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EBUS-TBNAExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EBUS-TBNA
2013
Completed Phase 4
~820
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
484,940 Total Patients Enrolled
Kazuhiro Yasufuku, MDPrincipal InvestigatorUHN
3 Previous Clinical Trials
431 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a specific lung biopsy before starting a targeted radiation treatment.You are not healthy enough to undergo a bronchoscopy procedure based on your overall medical condition.I can take care of myself and am up and about more than 50% of my waking hours.Patients need to have both CT and PET scans before joining the study.I cannot undergo surgery for my condition.I currently have an infection in my body, lungs, or around my heart.I am unable to understand and agree to the study's details.I am 18 years old or older.My cancer is confirmed as non-small cell lung cancer through testing.My cancer is in an early stage and hasn't spread far.I have chosen not to undergo surgery for my condition.I plan to undergo standard cancer treatments like chemotherapy or surgery.
Research Study Groups:
This trial has the following groups:- Group 1: EBUS-TBNA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available slots for patients to join the clinical trial?
"Affirmative. The clinicaltrial.gov database reveals that this trial, which was initially launched on February 1st 2021, is currently recruiting. Approximately 150 participants need to be sourced from a single site."
Answered by AI
What is the aggregate participation rate in this trial?
"Affirmative. Clinicaltrials.gov contains details confirming that this clinical trial is actively recruiting participants, beginning on February 1st 2013 and last updated on October 31st 2022. This experiment aims to enrol 150 volunteers from a single site."
Answered by AI
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