Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
- Conditions
- Lung Nodule
- Interventions
- Device: CT-Guided BiopsyDevice: Navigation bronchoscopy
- Registration Number
- NCT04250194
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 256
-
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.
-
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT-guided Biopsy CT-Guided Biopsy - Navigation Bronchoscopy (NB) with F-Nav Navigation bronchoscopy -
- Primary Outcome Measures
Name Time Method Diagnostic accuracy 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 Outcome Measures
Name Time Method Diagnostic yield 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.
Rate of pneumothorax Up to 12 months Proportion of cases complicated by pneumothorax
Rate of pneumothorax requiring chest tube placement Up to 12 months Proportion of cases complicated by pneumothorax requiring chest tube placement
Need for hospitalization after procedure Up to 12 months Proportion of cases with complication necessitating hospitalization after a procedure
Duration of procedure Up to 12 months Total time required to complete the procedure
Procedural factors associated with improved yield (type of biopsy) Up to 12 months Association of diagnostic yield with type of tools used to obtain biopsy
Procedural factors associated with improved yield (number of biopsies) Up to 12 months Association of diagnostic yield with count of biopsies
Procedural factors associated with improved yield (use of radial ultrasound) Up to 12 months Association of diagnostic yield with use of radial ultrasound
Procedural factors associated with improved yield (presence of a bronchus sign) Up to 12 months Association of diagnostic yield with presence of a bronchus sign
Procedural factors associated with improved yield (biopsy site) Up to 12 months Association of diagnostic yield with biopsy site (location)
Need for additional nodule biopsy Up to 12 months Proportion of cases in which additional invasive biopsy procedures directed at the targeted nodule were subsequently performed
Need for additional procedure for staging Up to 12 months Proportion of cases in which a subsequent procedure was performed for staging
Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy Up to 12 months Count of total radiation exposure from fluoroscopy-guided bronchoscopy
Radiation exposure from CT-guided biopsy Up to 12 months Count of total radiation exposure from fluoroscopy-guided bronchoscopy
Need for F-Nav during navigation bronchoscopy Up to 12 months Count of instances of need for F-Nav (digital tomosynthesis) during navigation bronchoscopy
Confident clinical diagnosis 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.
Trial Locations
- Locations (7)
University of California, San Diego
🇺🇸San Diego, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Kootenai Health
🇺🇸Coeur d'Alene, Idaho, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States