ARTEMIS is a multicenter randomized controlled trial. The goal is to understand whether rapid onsite evaluation during robotic assisted bronchoscopy improves the diagnostic performance of the procedure or not.
≥ 18 years of age at time of bronchoscopy
Undergoing robotic assisted bronchoscopy to biopsy a pulmonary lesion
Declines to participate or inability to provide informed consent.
Clinician determination that the use of ROSE is required or contraindicated for the optimal care of an individual patient
Patient enrolled in another trial that requires ROSE for PPL biopsy
Patient previously consented for this trial
Parallel
Rapid onsite evaluation
Other interventionROSE involves immediate intraprocedural microscopic assessment of biopsy specimens (typically by a cytotechnologist) to confirm adequacy of biopsy samples for malignant diagnosis during the bronchoscopy
Strict diagnostic yield, defined as the proportion of procedures that result in acquisition of lesional tissue.
Lesional tissue is defined by the presence of specific pathological findings that readily explain the presence of a pulmonary lesion. The following common pathological findings are pre-specified: 1. Malignancy 2. Specific benign pathologic findings including: organizing pneumonia, frank purulence/robust neutrophilic inflammation with a pathogen isolated, granulomatous inflammation, hamartoma, amyloidoma or other uncommon causes of peripheral pulmonary lesions with distinctive pathological patterns.
Sufficiency of malignant specimens for Next-Generation Sequencing
Proportion of malignant biopsies with sufficient material to send for NGS
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
AstraZeneca
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
