NCT06593106

Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage I Lung Cancer
• Stage II Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Cryosurgery	Undergo cryodevitalization
PROCEDURE	Robotic Bronchoscopy	Undergo standard of care robotic bronchoscopy with biopsy
PROCEDURE	Bronchoscopy with Biopsy	Undergo standard of care robotic bronchoscopy with biopsy
PROCEDURE	Resection	Undergo standard of care surgical resection
PROCEDURE	Chest Radiography	Undergo chest x-ray
PROCEDURE	Computed Tomography	Undergo Computed Tomography
PROCEDURE	Biospecimen Collection	Undergo tissue sample collection
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-07-30
• Completion: 2026-08-31
• First posted: 2024-09-19
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States