Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-04 @ 5:02 AM
Study NCT ID:
NCT04250194
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2020-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration, a Randomized Controlled Study (VERITAS)
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERITAS
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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-00632 | REGISTRY | NCI, Clinical Trials Reporting Program | View |