MDCT vs. CBCT Guided Percutaneous Lung Nodule Biopsy: A Comparison of Pneumothorax Incidence and Associated Risk Factors

NCT05344430 | Unknown DMC

• 1 other identifier: 20-1058-MATHER
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy

  rate of pneumothorax

  Up to 24 hours post biopsy procedure

Secondary Outcomes (3)

• To compare the difference in procedure times between biopsy imaging guidance modality

  immediately after the biopsy procedure

• To compare the amount of intravenous midazolam used between biopsy imaging guidance modality

  immediately after the biopsy procedure

• To compare the the amount of intravenous fentanyl used between biopsy imaging guidance modality

  immediately after the biopsy procedure

Study Arms (2)

cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy

OTHER

Cone beam Computed Tomography (CBCT) with Navigational software guidance for percutaneous transthoracic needle biopsy

Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy

multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy

OTHER

Multidetector Computer Tomography for percutaneous transthoracic needle biopsy

Procedure: cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy

Interventions

cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy PROCEDURE

We will be conducting cone beam computer tomography for percutaneous transthoracic needle biopsies.

cone beam computed tomography (CBCT) for percutaneous transthoracic needle biopsy; multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for lung biopsy at Mather Hospital's Department of Interventional Radiology.
• Patients ages from 18 years old to 90 years old.

You may not qualify if:

• High risk patients will be excluded from the study.
• ( High risk - Any patient with severe emphysema with bullous emphysema on baseline Computed Tomography of the Chest, intended biopsy target/nodule adjacent to an airway or central vasculature, or less than 1 cm in size)
• Patients less than 18 years old
• Patients older than 90 years old
• patients who lack mental capacity for medical decision making
• Any patient requiring or requesting general anesthesia for the intended procedure

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Mather Hospital Northwell Health

Port Jefferson, New York, 11777, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Kenny Lien, MD

  Interventional Radiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenny Lien, MD

CONTACT

631-473-1320; klien@northwell.edu

Greg Haggerty, PhD

CONTACT

516-551-8655; ghaggerty@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Radiologist

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 25, 2022
• Study Start: July 8, 2021
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)