NCT04250194 (VERITAS) is a NA clinical trial of CT-Guided Biopsy in Lung Nodule, sponsored by Vanderbilt-Ingram Cancer Center.

Who is sponsoring NCT04250194?

NCT04250194 is sponsored by Vanderbilt-Ingram Cancer Center.

What drugs are being tested in NCT04250194?

Interventions in NCT04250194: CT-Guided Biopsy, Navigation bronchoscopy.

What condition does NCT04250194 study?

NCT04250194 studies Lung Nodule.

Is NCT04250194 still recruiting?

NCT04250194 is currently completed. Last updated 29 September 2025.

Are results published for NCT04250194?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-09-29 · How we verify

NCT04250194: VERITAS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 29 September 2025

What this trial tests

NA trial testing CT-Guided Biopsy in Lung Nodule in 288 participants. Completed in 2 July 2024.

Timeline

22 May 2020

Primary endpoint
10 June 2024

2 July 2024

Quick facts

Lead sponsor	Vanderbilt-Ingram Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	288
Start date	22 May 2020
Primary completion	10 June 2024
Estimated completion	2 July 2024
Sites	7 locations across United States

Drugs / interventions tested

CT-Guided Biopsy
Navigation bronchoscopy

Conditions studied

Lung Nodule — all drugs for Lung Nodule →

Sponsor

Vanderbilt-Ingram Cancer Center — full company profile →

Who can join

18 and older, any sex, with Lung Nodule. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Accuracy Primary · Up to 12 months

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 (tru

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	94
CT-guided Biopsy	81

Diagnostic Yield Secondary · Up to 12 months

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.

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	96
CT-guided Biopsy	88

Rate of Pneumothorax Secondary · Up to 12 months

Proportion of cases complicated by pneumothorax

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	4
CT-guided Biopsy	32

Rate of Pneumothorax Requiring Chest Tube Placement Secondary · Up to 12 months

Proportion of cases complicated by pneumothorax requiring chest tube placement

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	1
CT-guided Biopsy	9

Need for Hospitalization After Procedure Secondary · Up to 12 months

Proportion of cases with complication necessitating hospitalization after a procedure

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	1
CT-guided Biopsy	13

Duration of Procedure Secondary · Up to 12 months

Total time required to complete the procedure

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	36	28 – 47.5
CT-guided Biopsy	24.5	13 – 36

Procedural Factors Associated With Improved Yield (Type of Biopsy) Secondary · Up to 12 months

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.

Transbronchial needle aspiration (TBNA)

Group	Value	95% CI
Overall	116
Diagnostic	93
Nondiagnostic	23

Transbronchial biopsy (TBB) using forceps

Group	Value	95% CI
Overall	76
Diagnostic	64
Nondiagnostic	12

Peripheral brushing with standard brush

Group	Value	95% CI
Overall	22
Diagnostic	17
Nondiagnostic	5

Triple needle brushing

Group	Value	95% CI
Overall	2
Diagnostic	2
Nondiagnostic	0

GenCut biopsy tool

Group	Value	95% CI
Overall	3
Diagnostic	1
Nondiagnostic	2

Peripheral wash via navigation catheter

Group	Value	95% CI
Overall	31
Diagnostic	22
Nondiagnostic	9

Any specimen cultured

Group	Value	95% CI
Overall	25
Diagnostic	15
Nondiagnostic	10

Procedural Factors Associated With Improved Yield (Number of Biopsies) Secondary · Up to 12 months

Association of diagnostic yield with count of biopsies. This outcome measure is only specific to the F-Nav bronchoscopy arm.

TBNA needle passes

Group	Value	95% CI
Overall	8.0	6.0 – 8.2
Diagnostic	8.0	6.0 – 8.0
Nondiagnostic	8.0	6.5 – 10.0

Forceps TBB pass count

Group	Value	95% CI
Overall	5.0	4.0 – 6.0
Diagnostic	5.0	4.0 – 6.0
Nondiagnostic	5.0	4.0 – 8.0

Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) Secondary · Up to 12 months

Association of diagnostic yield with use of radial ultrasound. This outcome measure is only specific to the F-Nav bronchoscopy arm.

Group	Value	95% CI
Overall	20
Diagnostic	20
Nondiagnostic	0
Overall	39
Diagnostic	30
Nondiagnostic	9
Overall	47
Diagnostic	32
Nondiagnostic	15
Overall	13
Diagnostic	12
Nondiagnostic	1

Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) Secondary · Up to 12 months

Association of diagnostic yield with presence of a bronchus sign

Presence of a bronchus sign

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	37
CT-guided Biopsy	30

Without a bronchus sign

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	59
CT-guided Biopsy	58

Procedural Factors Associated With Improved Yield (Biopsy Site) Secondary · Up to 12 months

Association of diagnostic yield with biopsy site (nodule location)

Nodule is in outer-third zone

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	86
CT-guided Biopsy	77

Nodule is in middle-third zone

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	10
CT-guided Biopsy	11

Need for Additional Nodule Biopsy Secondary · Up to 12 months

Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed

Group	Value	95% CI
Navigation Bronchoscopy (NB) With F-Nav	16
CT-guided Biopsy	15

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Navigation Bronchoscopy (NB) With F-Nav

Serious: 2/121 (2%)

Deaths: 0/121

CT-guided Biopsy

Serious: 14/113 (12%)

Deaths: 0/113

Serious adverse events (2 terms)

Reaction	System	Navigation Bronchoscopy (N…	CT-guided Biopsy
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Navigation Bronchoscopy (N…	CT-guided Biopsy
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Hemorrhage requiring intervention	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Pneumothorax, Respiratory failure.

Data from ClinicalTrials.gov NCT04250194 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.
Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, et al · · 2025 · cited 49× · PMID 40387025 · DOI 10.1056/nejmoa2414059
Robotic-assisted bronchoscopy: a narrative review of systems.
Fernandez-Bussy S, Chandra NC, Koratala A, Yu Lee-Mateus A, et al · · 2024 · cited 19× · PMID 39268090 · DOI 10.21037/jtd-24-456
Keeping Up With Technological Innovation: The Moral Imperative for Pragmatic Clinical Trials in Interventional Pulmonology.
Maldonado F, Paez R, Lentz RJ, Ratwani A, et al · · 2025 · cited 5× · PMID 39577764 · DOI 10.1016/j.chest.2024.11.010
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
Lentz RJ, Frederick-Dyer K, Planz VB, Koyama T, et al · · 2023 · DOI 10.1101/2023.11.22.23298915
Navigational bronchoscopy specimens and PD-L1 expression: a retrospective study.
Asad H, Saettele T, Tawfik O, Jones P, et al · · 2022 · PMID 35280465 · DOI 10.21037/jtd-21-1454

Verify or expand the search:

Other recruiting trials for Lung Nodule

Currently open trials in the same condition.

NCT06597968 — Evaluating the Real World Performance of an AI Based Lung Nodule Detection Tool · recruiting
NCT07098884 — Artificial Intelligence for Pathology Diagnosis and Prognosis Prediction of Lung Nodule Using Smartphone Photos · recruiting
NCT06838806 — Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation · recruiting
NCT06054854 — Biobank for the Identification of Biomarkers in Lung Cancer (BIRD, Biomarkers in Respiratory Disease) · recruiting

Other Vanderbilt-Ingram Cancer Center trials

Trials by the same sponsor.

NCT06638398 — Biomarker Platform (Virtual Nodule Clinic) for the Management of Indeterminate Pulmonary Nodules · NA · active not recruiting
NCT06593106 — Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial · NA · recruiting
NCT06105801 — EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing · Phase 4 · recruiting
NCT06399640 — Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06016855 — Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroend · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04250194 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center
Last refreshed: 29 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04250194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing