The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
Vanderbilt-Ingram Cancer Center
Summary
This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection * Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral org…
Interventions
- ProcedureCryosurgery
Undergo cryodevitalization
- ProcedureRobotic Bronchoscopy
Undergo standard of care robotic bronchoscopy with biopsy
- ProcedureBronchoscopy with Biopsy
Undergo standard of care robotic bronchoscopy with biopsy
- ProcedureResection
Undergo standard of care surgical resection
- ProcedureChest Radiography
Undergo chest x-ray
- ProcedureComputed Tomography
Undergo Computed Tomography
- ProcedureBiospecimen Collection
Location
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee