N/A N=258 Randomized Diagnostic

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

Lung Nodule

Bottom Line

View on ClinicalTrials.gov: NCT04250194 ↗

Enrolled (actual)

258

Serious AEs

6.8%

Results posted

Jul 2025

Primary outcome: Primary: Diagnostic Accuracy — 94; 81 Participants — p=0.003

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CT-Guided Biopsy (Device); Navigation bronchoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt-Ingram Cancer Center
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnostic Accuracy	94; 81	0.003 sig
SECONDARY Diagnostic Yield	96; 88	—
SECONDARY Rate of Pneumothorax	4; 32	—
SECONDARY Rate of Pneumothorax Requiring Chest Tube Placement	1; 9	—
SECONDARY Need for Hospitalization After Procedure	1; 13	—
SECONDARY Duration of Procedure	36; 24.5	—
SECONDARY Procedural Factors Associated With Improved Yield (Type of Biopsy)	116; 93; 23; 76; 64; 12	—
SECONDARY Procedural Factors Associated With Improved Yield (Number of Biopsies)	8.0; 8.0; 8.0; 5.0; 5.0; 5.0	—
SECONDARY Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)	20; 20; 0; 39; 30; 9	—
SECONDARY Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)	37; 30; 59; 58	—
SECONDARY Procedural Factors Associated With Improved Yield (Biopsy Site)	86; 77; 10; 11	—
SECONDARY Need for Additional Nodule Biopsy	16; 15	—
SECONDARY Need for Additional Procedure for Staging	0; 3	—
SECONDARY Radiation Exposure From Fluoroscopy-guided Bronchoscopy	9800	—
SECONDARY Need for F-Nav During Navigation Bronchoscopy	96; 71; 25	—
SECONDARY Confident Clinical Diagnosis	96; 88	—
SECONDARY Radiation Exposure From CT for CT-guided Biopsy	659	—
SECONDARY Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group	6; 4; 2; 75; 64; 11	—

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.

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04250194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.