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: Completed
• Conditions: Lung Nodule
• Intervention / Treatment: Device: Navigation bronchoscopy; Device: CT-Guided Biopsy

Detailed Description

Endpoints:

Primary:

• To evaluate diagnostic accuracy through 12 months of clinical follow-up

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 (digital tomosynthesis) during navigation bronchoscopy.
• To evaluate diagnostic yield
• To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).

• Study Type: Interventional
• Enrollment (Actual): 288
• 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: 14 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 Accuracy	Proportion of biopsies leading to a definitive diagnosis, comparing the bronchoscopy pathway to the CT-guided biopsy pathway. Definitive diagnoses are pre-defined as any of the following: Malignant, OR; Abnormal tissue (excluding normal or absence of lung parenchyma) followed by a surgical lung biopsy yielding the same histological diagnosis, OR; Specific benign histopathologic finding which accounts for the presence of a lung nodule (specifically including organizing pneumonia, frank purulence, granulomatous inflammation, or other specific benign finding) AND; Absence of malignancy (true negative) through 1-year CT follow-up, defined as:The nodule markedly regresses or resolves on follow-up imaging, ORA persistent nodule has not been diagnosed as malignant, ANDNo plans for repeat invasive diagnostic procedures through 12 months follow-up. Normal or absence of lung parenchyma, atypia and non-specific inflammation will be considered non-diagnostic.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Yield	Rate at which histopathology is obtained which explains the presence of a nodule (according to definitions set forth for the primary endpoint) and permits post-biopsy clinical decision-making without need for immediate additional diagnostic procedures.	Up to 12 months
Rate of Pneumothorax	Proportion of cases complicated by pneumothorax	Up to 12 months
Rate of Pneumothorax Requiring Chest Tube Placement	Proportion of cases complicated by pneumothorax requiring chest tube placement	Up to 12 months
Need for Hospitalization After Procedure	Proportion of cases with complication necessitating 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)	Association of diagnostic yield with type of tools used to obtain biopsy: F-Nav Bronchoscopy group. This outcome measure is only applicable to the patients randomized to the navigational bronchoscopy platform.	Up to 12 months
Procedural Factors Associated With Improved Yield (Number of Biopsies)	Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.	Up to 12 months
Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)	Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.	Up to 12 months
Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)	Association of diagnostic yield with presence of a bronchus sign	Up to 12 months
Procedural Factors Associated With Improved Yield (Biopsy Site)	Association of diagnostic yield with biopsy site (nodule location)	Up to 12 months
Need for Additional Nodule Biopsy	Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed	Up to 12 months
Need for Additional Procedure for Staging	Proportion of cases in which a subsequent procedure was performed for staging	Up to 12 months
Radiation Exposure From Fluoroscopy-guided Bronchoscopy	Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy*cm^2)	Up to 12 months
Need for F-Nav During Navigation Bronchoscopy	Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.	Up to 12 months
Confident Clinical Diagnosis	The proportion of biopsy procedures yielding a confident clinical diagnosis including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens.	Up to 12 months
Radiation Exposure From CT for CT-guided Biopsy	Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy*cm)	Up to 12 months
Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group	Association of diagnostic yield with type of tools used to obtain biopsy: CT-guided group. This outcome measure is only applicable to the patients randomized to the CT-guided procedure.	Up to 12 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Avasarala SK, Casey JD, Cheng GZ, D'Haese PF, Duke JD, Grogan EL, Hoopman TC, Johnson J, Katsis JM, Kurman JS, Low SW, Mahmood K, Rickman OB, Roller L, Salmon C, Shojaee S, Swanner B, Wahidi MM, Walston C, Silvestri GA, Yarmus L, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules. N Engl J Med. 2025 Jun 5;392(21):2100-2112. doi: 10.1056/NEJMoa2414059. Epub 2025 May 18.
• Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, Aboudara MC, Swanner B, Roller L, Low SW, Salmon C, Avasarala SK, Hoopman TC, Wahidi MM, Mahmood K, Cheng GZ, Katsis JM, Kurman JS, D'Haese PF, Johnson J, Grogan EL, Walston C, Yarmus L, Silvestri GA, Rickman OB, Rahman NM, Maldonado F. Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial. medRxiv [Preprint]. 2023 Nov 23:2023.11.22.23298915. doi: 10.1101/2023.11.22.23298915.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): July 2, 2024

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 (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

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