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

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ClinicalTrials.gov Identifier: NCT04250194
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Fabien Maldonado, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Nodule Device: CT-Guided Biopsy Device: Navigation bronchoscopy Not Applicable

Detailed Description:

Endpoints:

Primary:

• To evaluate diagnostic yield

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 during navigation bronchoscopy.
  • To evaluate bronchoscopy yield defined as the combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : September 28, 2023
Estimated Study Completion Date : September 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Arm Intervention/treatment
Experimental: Navigation Bronchoscopy (NB) with F-Nav Device: Navigation bronchoscopy
A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy

Experimental: CT-guided Biopsy Device: 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




Primary Outcome Measures :
  1. Diagnostic yield [ Time Frame: Up to 12 months ]
    Rate of technically successful biopsies leading to a definitive diagnosis


Secondary Outcome Measures :
  1. Rate of pneumothorax [ Time Frame: Up to 12 months ]
    Number of instances of pneumothorax

  2. Rate of pneumothorax requiring chest tube placement [ Time Frame: Up to 12 months ]
    Number of instances of pneumothorax requiring chest tube placement

  3. Need for hospitalization after procedure [ Time Frame: Up to 12 months ]
    Number of instances of hospitalization after a procedure

  4. Duration of procedure [ Time Frame: Up to 12 months ]
    Total time required to complete the procedure

  5. Procedural factors associated with improved yield (type of biopsy) [ Time Frame: Up to 12 months ]
    Count of type of biopsy

  6. Procedural factors associated with improved yield (number of biopsies) [ Time Frame: Up to 12 months ]
    Count of biopsies

  7. Procedural factors associated with improved yield (use of radial ultrasound) [ Time Frame: Up to 12 months ]
    Number of instances of use of radial ultrasound

  8. Procedural factors associated with improved yield (presence of a bronchus sign) [ Time Frame: Up to 12 months ]
    Count of presence of a bronchus sign

  9. Procedural factors associated with improved yield (biopsy site) [ Time Frame: Up to 12 months ]
    Count of biopsy site

  10. Need for additional nodule biopsy [ Time Frame: Up to 12 months ]
    Count of instances of need for an additional nodule biopsy

  11. Need for additional procedure for staging [ Time Frame: Up to 12 months ]
    Count of instances of need of an additional procedure for staging

  12. Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy [ Time Frame: Up to 12 months ]
    Count of total radiation exposure from fluoroscopy-guided bronchoscopy

  13. Radiation exposure from CT-guided biopsy [ Time Frame: Up to 12 months ]
    Count of total radiation exposure from fluoroscopy-guided bronchoscopy

  14. Need for F-Nav during navigation bronchoscopy [ Time Frame: Up to 12 months ]
    Count of instances of need for F-Nav during navigation bronchoscopy

  15. Bronchoscopy yield [ Time Frame: Up to 12 months ]
    The combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 70%, 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250194


Contacts
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Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 cip@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Service         
Principal Investigator: Fabien Maldonado, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Medtronic
Investigators
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Principal Investigator: Fabien Maldonado, MD Vanderbilt-Ingram Cancer Center
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Responsible Party: Fabien Maldonado, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04250194    
Other Study ID Numbers: VICC THO 19102
NCI-2020-00632 ( Registry Identifier: NCI, Clinical Trials Reporting Program )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No