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

NCT ID: NCT04250194

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2024-07-02

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. 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.

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).

Conditions

Lung Nodule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Navigation Bronchoscopy (NB) with F-Nav

Group Type: EXPERIMENTAL

Navigation bronchoscopy

Intervention Type: DEVICE

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

CT-guided Biopsy

Group Type: EXPERIMENTAL

CT-Guided Biopsy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Navigation bronchoscopy

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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Fabien Maldonado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabien Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

University of California, San Diego

San Diego, California, United States

Kootenai Health

Coeur d'Alene, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40387025 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38045245 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2020-00632

Identifier Type: REGISTRY

Identifier Source: secondary_id

VICC THO 19102

Identifier Type: -

Identifier Source: org_study_id