Treatment for Lung Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mather Hospital Northwell Health, Port Jefferson, NY
Lung Diseases+1 More
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The goal of this study is to determine if cone beam computed tomography (CBCT) is a viable alternative imaging guidance modality for percutaneous transthoracic needle biopsy (PTNB) in a community hospital-based practice, and to determine the incidence of CBCT PTNB-associated pneumothorax compared to multidetector computed tomography (MDCT) guided PTNB biopsy. The standard of care in this facility is MDCT guided PTNB biopsy. The experimental arm of this study is CBCT-guided PTNB biopsy. This prospective study will identify patients planned for PTNB. Thereafter, data on lesion characteristics, imaging findings, and clinical history will be collected. Patients will be subsequently randomly assigned to undergo biopsy using either CBCT or MDCT guidance. This study will analyze the pneumothorax incidence between groups, and assess for associations between lesion size/location, pertinent imaging findings, and clinical risk factors.

Eligible Conditions

  • Lung Diseases

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: immediately after the biopsy procedure

Hour 24
To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy
immediately after the biopsy procedure
To compare the amount of intravenous midazolam used between biopsy imaging guidance modality
To compare the difference in procedure times between biopsy imaging guidance modality
To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality

Trial Safety

Trial Design

0 Treatment Group

100 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: immediately after the biopsy procedure
Closest Location: Mather Hospital Northwell Health · Port Jefferson, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Lung Diseases
0 CompletedClinical Trials

Who is running the clinical trial?

Northwell HealthLead Sponsor
409 Previous Clinical Trials
290,110 Total Patients Enrolled
2 Trials studying Lung Diseases
166 Patients Enrolled for Lung Diseases
Kenny Lien, MDPrincipal InvestigatorInterventional Radiologist
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.