Recruiting

MDCT vs. CBCT

Sponsor:

Northwell Health

Code:

NCT05344430

Conditions

Lung Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05344430

Start date

Jul 8, 2021

Status verified date

May, 2023

Completion date

Jul 8, 2024

Anticipated

Primary completion date

Jul 8, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

other: multidetector computed tomography (MDCT) for percutaneous transthoracic needle biopsy

Multidetector Computer Tomography for percutaneous transthoracic needle biopsy

Interventions

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

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

Primary outcome measure

  • To determine the incidence of pneumothorax as a complication of CBCT and CT-guided percutaneous lung biopsy [ Time Frame: Up to 24 hours post biopsy procedure ]

Central Contacts and Locations

Central contacts

Kenny Lien, MD

631-473-1320klien@northwell.edu

Greg Haggerty, PhD

516-551-8655ghaggerty@northwell.edu

Locations

Mather Hospital Northwell Health

Recruiting

Port Jefferson, New York, United States, 11777

Contacts

Kenny Lien, MD

631-473-1320klien@northwell.edu

Greg Haggerty, PhD

516-551-8655ghaggerty@northwell.edu

Principal Investigator:

Kenny Lien, MD

More Information

Sponsor

Northwell Health

Last update posted

May 16, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2023-05-16.