Clinical trial NCT04250194: Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Official title: Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Nodule
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2020-01-31
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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).

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Up to 12 months
Secondary outcomes:
measure: Diagnostic yield
timeFrame: Up to 12 months
measure: Rate of pneumothorax
timeFrame: Up to 12 months
measure: Rate of pneumothorax requiring chest tube placement
timeFrame: Up to 12 months
measure: Need for hospitalization after procedure
timeFrame: Up to 12 months
measure: Duration of procedure
timeFrame: Up to 12 months
measure: Procedural factors associated with improved yield (type of biopsy)
timeFrame: Up to 12 months
measure: Procedural factors associated with improved yield (number of biopsies)
timeFrame: Up to 12 months
measure: Procedural factors associated with improved yield (use of radial ultrasound)
timeFrame: Up to 12 months
measure: Procedural factors associated with improved yield (presence of a bronchus sign)
timeFrame: Up to 12 months
measure: Procedural factors associated with improved yield (biopsy site)
timeFrame: Up to 12 months
measure: Need for additional nodule biopsy
timeFrame: Up to 12 months
measure: Need for additional procedure for staging
timeFrame: Up to 12 months
measure: Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy
timeFrame: Up to 12 months
measure: Radiation exposure from CT-guided biopsy
timeFrame: Up to 12 months
measure: Need for F-Nav during navigation bronchoscopy
timeFrame: Up to 12 months
measure: Confident clinical diagnosis
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Fabien Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: