Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration (VERITAS)

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)

This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:

1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Nodule
• Intervention / Treatment: Device: Navigation bronchoscopy; Device: CT-Guided Biopsy

Detailed Description

Endpoints:

Primary:

• To evaluate diagnostic yield

Secondary:

• To evaluate rate of pneumothorax.
• To evaluate rate of pneumothorax requiring chest tube placement.
• To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
• To evaluate need for hospitalization after procedure.
• To evaluate duration of the procedure.
• To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
• To evaluate need for additional nodule biopsy.
• To evaluate need for additional procedure for staging.
• To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
• To evaluate need for F-Nav during navigation bronchoscopy.
• To evaluate bronchoscopy yield defined as the combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • University of California, San Diego
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • Kootenai Health
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:

  • Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:

    • The Brock model14 if no PET scan data are available, or
    • The Herder model15 if PET-CT data are available.
  • Size between 10 and 30 mm (long diameter).
  • Location peripheral, here defined as occupying the middle or outer third lung zones.
  • Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.

Exclusion Criteria:

• Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
• Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Navigation Bronchoscopy (NB) with F-Nav	Device: Navigation bronchoscopy; A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy
Experimental: CT-guided Biopsy	Device: CT-Guided Biopsy; Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Rate of technically successful biopsies leading to a definitive diagnosis	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of pneumothorax	Number of instances of pneumothorax	Up to 12 months
Rate of pneumothorax requiring chest tube placement	Number of instances of pneumothorax requiring chest tube placement	Up to 12 months
Need for hospitalization after procedure	Number of instances of hospitalization after a procedure	Up to 12 months
Duration of procedure	Total time required to complete the procedure	Up to 12 months
Procedural factors associated with improved yield (type of biopsy)	Count of type of biopsy	Up to 12 months
Procedural factors associated with improved yield (number of biopsies)	Count of biopsies	Up to 12 months
Procedural factors associated with improved yield (use of radial ultrasound)	Number of instances of use of radial ultrasound	Up to 12 months
Procedural factors associated with improved yield (presence of a bronchus sign)	Count of presence of a bronchus sign	Up to 12 months
Procedural factors associated with improved yield (biopsy site)	Count of biopsy site	Up to 12 months
Need for additional nodule biopsy	Count of instances of need for an additional nodule biopsy	Up to 12 months
Need for additional procedure for staging	Count of instances of need of an additional procedure for staging	Up to 12 months
Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy	Count of total radiation exposure from fluoroscopy-guided bronchoscopy	Up to 12 months
Radiation exposure from CT-guided biopsy	Count of total radiation exposure from fluoroscopy-guided bronchoscopy	Up to 12 months
Need for F-Nav during navigation bronchoscopy	Count of instances of need for F-Nav during navigation bronchoscopy	Up to 12 months
Bronchoscopy yield	The combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.	Up to 12 months

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Fabien Maldonado, MD, Vanderbilt-Ingram Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VICC THO 19102; NCI-2020-00632 (Registry Identifier: NCI, Clinical Trials Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No