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Procedure
CBCT-Guided Bronchoscopy for Lung Nodules
N/A
Recruiting
Led By Fayez Kheir, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with higher risk lesions (pCA > 0.65) in need of a diagnosis for nonsurgical treatment or prior to surgery
Participants must be ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing if a CBCT-guided navigation bronchoscopy is better than a regular navigation bronchoscopy in finding lung nodules.
Who is the study for?
This trial is for adults with lung nodules that might be cancerous, as calculated by a specific risk calculator. They should need a biopsy and not have plans for certain radiation therapy if the biopsy doesn't diagnose the problem. People can't join if they have serious heart issues, are pregnant, unfit for bronchoscopy, allergic to lidocaine, or cannot stop blood thinners temporarily.Check my eligibility
What is being tested?
The study is testing whether using cone beam computed tomography (CBCT) alongside navigation bronchoscopy improves diagnosis of lung nodules compared to just navigation bronchoscopy. It aims to see which method is better at finding out if these nodules are cancerous.See study design
What are the potential side effects?
While not explicitly listed in your information provided, side effects from procedures like CBCT-guided navigation bronchoscopy could include discomfort at the site of procedure, bleeding, infection risk and potential reactions to any contrast material used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a high-risk lesion and need a diagnosis before starting treatment or surgery.
Select...
I am 18 years old or older.
Select...
My lung nodule is likely cancerous, and my doctor recommends a bronchoscopic biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Diagnostic Yield
Secondary outcome measures
Additional diagnostic procedures in navigational bronchoscopy alone and CBCT guided bronchoscopy.
Navigational time in bronchoscopy alone and CBCT guided bronchoscopy.
Overall incidence of procedure-related complications
Trial Design
2Treatment groups
Experimental Treatment
Group I: Navigation Bronchoscopy ALONEExperimental Treatment1 Intervention
This research study involves a screening period, a procedure and follow up visits
Procedure Visit Navigation Bronchoscopy Alone
Follow-Up Visits at Week 1, 4 and 12
Group II: CBCT-GUIDED Navigation BronchoscopyExperimental Treatment2 Interventions
This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules
-Follow-Up Visits at Week 1, 4 and 12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cone beam computed tomography (CBCT)
2009
N/A
~40
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,200 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,812 Total Patients Enrolled
Philips HealthcareIndustry Sponsor
125 Previous Clinical Trials
282,190 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to lidocaine.I have a bleeding disorder that cannot be controlled or reversed.I have high blood pressure in the lungs that is not under control.I have a high-risk lesion and need a diagnosis before starting treatment or surgery.My doctor thinks I'm not fit for a bronchoscopy.If my lung nodule test is unclear, I will have SBRT instead of a CT-guided biopsy.I cannot stop my blood thinner medication temporarily.I have heart problems that started or weren't controlled in the last month.I am 18 years old or older.I have a condition that makes it unsafe to access my lungs through my airway.My lung nodule is likely cancerous, and my doctor recommends a bronchoscopic biopsy.You have a medical condition that is very serious.I am currently COVID-19 positive.
Research Study Groups:
This trial has the following groups:- Group 1: Navigation Bronchoscopy ALONE
- Group 2: CBCT-GUIDED Navigation Bronchoscopy
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 participants still being accepted for this clinical experiment?
"Affirmative. Clinicaltrials.gov's data indicates that the study, which was initially listed on March 5th 2021, is recruiting patients now. The medical trial seeks to find 136 participants from a single site."
Answered by AI
What is the aggregate amount of participants involved in this research endeavor?
"Indeed, according to clinicaltrials.gov the trial is currently recruiting participants; the first posting was made on March 5th 2021 and recently updated August 4th 2022. 136 people are needed for this study which will take place at a single site."
Answered by AI
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