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

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

NCT ID: NCT06593106

Condition: Stage I Lung Cancer
Stage II Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Cryosurgery
Description: Undergo cryodevitalization
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Robotic Bronchoscopy
Description: Undergo standard of care robotic bronchoscopy with biopsy
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Bronchoscopy with Biopsy
Description: Undergo standard of care robotic bronchoscopy with biopsy
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Resection
Description: Undergo standard of care surgical resection
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Chest Radiography
Description: Undergo chest x-ray
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo Computed Tomography
Arm group label: Treatment

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo tissue sample collection
Arm group label: Treatment

Intervention type: Other
Intervention name: Electronic Health Record Review
Description: Ancillary studies
Arm group label: Treatment

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.

Criteria for eligibility:
Criteria:
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 organs - Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) > 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board - Age > 18 years old Exclusion Criteria: - Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic & laryngeal nerves), or are < 10 mm from the pleura - Patients with an expected survival less than 6 months - Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways - Patients with medically uncorrectable coagulopathy: abnormal platelet count < 100 × 10^9/L or an international normalized ratio > 1.5 - Patients with known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg) - Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors - Patients with medical comorbidities deemed high-risk for surgical resection - Pregnant women - Inability to provide informed consent

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Vanderbilt University/Ingram Cancer Center

Address:
City: Nashville
Zip: 37203
Country: United States

Status: Recruiting

Contact:
Last name: Vanderbilt-Ingram Service for Timely Access

Phone: 800-811-8480
Email: cip@vumc.org

Investigator:
Last name: Fabien Maldonado, MD
Email: Principal Investigator

Start date: October 24, 2024

Completion date: August 31, 2026

Lead sponsor:
Agency: Vanderbilt-Ingram Cancer Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Collaborator:
Agency: Swim Across America
Agency class: Other

Source: Vanderbilt-Ingram Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06593106