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Completed

NCT Number: NCT04250194

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

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.

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Key information

Conditions

Lung Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, San Diego, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CT-Guided Biopsy

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

Navigation bronchoscopy

Device

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

Primary outcomes

  1. Diagnostic Accuracy

    Time frame: 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 (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.

Secondary outcomes

  1. Diagnostic Yield

    Time frame: 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.

  2. Rate of Pneumothorax

    Time frame: Up to 12 months

    Proportion of cases complicated by pneumothorax

  3. Rate of Pneumothorax Requiring Chest Tube Placement

    Time frame: Up to 12 months

    Proportion of cases complicated by pneumothorax requiring chest tube placement

  4. Need for Hospitalization After Procedure

    Time frame: Up to 12 months

    Proportion of cases with complication necessitating hospitalization after a procedure

  5. Duration of Procedure

    Time frame: Up to 12 months

    Total time required to complete the procedure

  6. Procedural Factors Associated With Improved Yield (Type of Biopsy)

    Time frame: 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.

  7. Procedural Factors Associated With Improved Yield (Number of Biopsies)

    Time frame: Up to 12 months

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

  8. Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound)

    Time frame: 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.

  9. Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign)

    Time frame: Up to 12 months

    Association of diagnostic yield with presence of a bronchus sign

  10. Procedural Factors Associated With Improved Yield (Biopsy Site)

    Time frame: Up to 12 months

    Association of diagnostic yield with biopsy site (nodule location)

  11. Need for Additional Nodule Biopsy

    Time frame: Up to 12 months

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

  12. Need for Additional Procedure for Staging

    Time frame: Up to 12 months

    Proportion of cases in which a subsequent procedure was performed for staging

  13. Radiation Exposure From Fluoroscopy-guided Bronchoscopy

    Time frame: Up to 12 months

    Count of total radiation exposure from fluoroscopy-guided bronchoscopy (units mGy*cm^2)

  14. Need for F-Nav During Navigation Bronchoscopy

    Time frame: Up to 12 months

    Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy. This outcome measure pertains only for the F-Nav bronchoscopy arm.

  15. Confident Clinical Diagnosis

    Time frame: Up to 12 months

    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.

  16. Radiation Exposure From CT for CT-guided Biopsy

    Time frame: Up to 12 months

    Count of total radiation exposure CT-guided transthoracic biopsy (units of mGy*cm)

  17. Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group

    Time frame: Up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • Medtronic

Registry information

Official study title

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)

Acronym: VERITAS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2020
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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