Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by George Cheng, MD
Headshot of George Cheng
George Cheng

Description

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.

Official Title

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

Details

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.

Keywords

Lung Nodule CT-Guided Biopsy Navigation bronchoscopy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92037 United States
  • Saint Luke's Hospital of Kansas City accepting new patients
    Kansas City Missouri 64111 United States

Lead Scientist at UCSD

  • George Cheng, MD
    Associate Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 10 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt-Ingram Cancer Center
ID
NCT04250194
Study Type
Interventional
Participants
Expecting 258 study participants
Last Updated