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CBCT-Guided Biopsy for Lung Disease
N/A
Recruiting
Led By Kenny Lien, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the biopsy procedure
Awards & highlights
Study Summary
This trial is testing whether cone beam computed tomography (CBCT) is a viable alternative to the standard imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital setting.
Who is the study for?
This trial is for adults aged 18-90 scheduled for lung biopsy at Mather Hospital's Department of Interventional Radiology. It excludes those under 18, lacking decision-making capacity, needing general anesthesia, or high-risk patients with severe emphysema, targets near airways/central vessels, or very small nodules.Check my eligibility
What is being tested?
The study compares two imaging techniques used during lung biopsies: the standard multidetector computed tomography (MDCT) and the experimental cone beam computed tomography (CBCT). The aim is to see if CBCT reduces the risk of a collapsed lung compared to MDCT.See study design
What are the potential side effects?
Potential side effects include risks associated with percutaneous transthoracic needle biopsy such as pneumothorax (collapsed lung), bleeding, infection at the puncture site, and discomfort from the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the biopsy procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the biopsy procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy
Secondary outcome measures
To compare the amount of intravenous midazolam used between biopsy imaging guidance modality
Interventional procedure
To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality
Trial Design
2Treatment groups
Experimental Treatment
Group I: multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsyExperimental Treatment1 Intervention
Multidetector Computer Tomography for percutaneous transthoracic needle biopsy
Group II: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsyExperimental Treatment1 Intervention
Cone beam Computed Tomography (CBCT) with Navigational software guidance for percutaneous transthoracic needle biopsy
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,833 Total Patients Enrolled
Kenny Lien, MDPrincipal InvestigatorInterventional Radiologist
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 90 years old.I do not have severe emphysema or very small lung nodules near major airways or blood vessels.I am under 18 years old.I am between 18 and 90 years old.I am unable to make medical decisions for myself.I need or want general anesthesia for my procedure.
Research Study Groups:
This trial has the following groups:- Group 1: multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy
- Group 2: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy
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 geriatric patients eligible for this research project?
"The age limits for this trial are 18 to 90. If a patient does not fall in this category, there are 32 other trials that might be more appropriate. There are 293 trials for patients over 65."
Answered by AI
Are people with pre-existing conditions able to join this research initiative?
"The requirements to participate in this study include being between 18 and 90 years old and having a pre-existing lung condition. Currently, the study has 100 open slots for candidates."
Answered by AI
How many participants will this trial be testing?
"That is accurate. The clinical trial in question, which was originally posted on July 8th 2021, is still recruiting patients. They are looking for 100 people to enroll, and the trial is happening at 1 location."
Answered by AI
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