NCT04250194

Brief Summary

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 22, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 14, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

4.1 years

First QC Date

January 29, 2020

Results QC Date

May 20, 2025

Last Update Submit

September 15, 2025

Conditions

Lung Nodule

Outcome Measures

Primary Outcomes (1)

  • 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, OR * A persistent nodule has not been diagnosed as malignant, AND * No 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 Outcomes (17)

  • Diagnostic Yield

    Up to 12 months

  • Rate of Pneumothorax

    Up to 12 months

  • Rate of Pneumothorax Requiring Chest Tube Placement

    Up to 12 months

  • Need for Hospitalization After Procedure

    Up to 12 months

  • Duration of Procedure

    Up to 12 months

  • +12 more secondary outcomes

Study Arms (2)

Navigation Bronchoscopy (NB) with F-Nav

EXPERIMENTAL
Device: Navigation bronchoscopy

CT-guided Biopsy

EXPERIMENTAL
Device: CT-Guided Biopsy

Interventions

CT-Guided BiopsyDEVICE

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

CT-guided Biopsy
Navigation bronchoscopyDEVICE

A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy

Navigation Bronchoscopy (NB) with F-Nav

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California, San Diego

San Diego, California, 92037, United States

Location

Kootenai Health

Coeur d'Alene, Idaho, 83814, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • 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.

    PMID: 40387025DERIVED

  • 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.

    PMID: 38045245DERIVED

Results Point of Contact

Title
Dr. Fabien Maldonado
Organization
Vanderbilt University Medical Center
fabien.maldonado@vumc.org
615-322-2386

Study Officials

  • Fabien Maldonado, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

May 22, 2020

Primary Completion

June 10, 2024

Study Completion

July 2, 2024

Last Updated

September 29, 2025

Results First Posted

July 14, 2025

Record last verified: 2025-09

Locations

US(7)