Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
Description
PRIMARY OBJECTIVE:
I. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration.
OUTLINE: This is a dose-escalation study.
Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest radiography (x-ray) on study as well as computed tomography (CT) and tissue sample collection throughout the study.
After completion of study treatment, patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months.
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