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

Lung Nodule Clinical Trial

— VERITAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04250194
• Other study ID #: VICC THO 19102
• Secondary ID: NCI-2020-00632
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Nodule

Intervention

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Kootenai Health	Coeur d'Alene	Idaho
United States	Duke University Medical Center	Durham	North Carolina
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	University of California, San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	Rate of technically successful biopsies leading to a definitive diagnosis	Up to 12 months
Secondary	Rate of pneumothorax	Number of instances of pneumothorax	Up to 12 months
Secondary	Rate of pneumothorax requiring chest tube placement	Number of instances of pneumothorax requiring chest tube placement	Up to 12 months
Secondary	Need for hospitalization after procedure	Number of instances of hospitalization after a procedure	Up to 12 months
Secondary	Duration of procedure	Total time required to complete the procedure	Up to 12 months
Secondary	Procedural factors associated with improved yield (type of biopsy)	Count of type of biopsy	Up to 12 months
Secondary	Procedural factors associated with improved yield (number of biopsies)	Count of biopsies	Up to 12 months
Secondary	Procedural factors associated with improved yield (use of radial ultrasound)	Number of instances of use of radial ultrasound	Up to 12 months
Secondary	Procedural factors associated with improved yield (presence of a bronchus sign)	Count of presence of a bronchus sign	Up to 12 months
Secondary	Procedural factors associated with improved yield (biopsy site)	Count of biopsy site	Up to 12 months
Secondary	Need for additional nodule biopsy	Count of instances of need for an additional nodule biopsy	Up to 12 months
Secondary	Need for additional procedure for staging	Count of instances of need of an additional procedure for staging	Up to 12 months
Secondary	Radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy	Count of total radiation exposure from fluoroscopy-guided bronchoscopy	Up to 12 months
Secondary	Radiation exposure from CT-guided biopsy	Count of total radiation exposure from fluoroscopy-guided bronchoscopy	Up to 12 months
Secondary	Need for F-Nav during navigation bronchoscopy	Count of instances of need for F-Nav during navigation bronchoscopy	Up to 12 months
Secondary	Bronchoscopy yield	The combination of the primary endpoint (navigation diagnostic yield) and yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies.	Up to 12 months