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

Vanderbilt University Medical Center

Status: Begins enrollment in 1 month

Conditions: Stage II Lung Cancer; Stage I Lung Cancer

Treatments: Procedure: Robotic Bronchoscopy; Procedure: Resection; Other: Electronic Health Record Review; Procedure: Bronchoscopy with Biopsy; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Procedure: Cryosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06593106

P30CA068485 (U.S. NIH Grant/Contract)

NCI-2024-07299 (Registry Identifier)

VICC-VCTHO24099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a single pulmonary nodule with a size less than two centimeters (average long and short axis) confirmed as lung cancer intraprocedurally (rapid on-site evaluation with pathology assessment) 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment

Experimental group

Description:

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 x-ray on study as well as CT and tissue sample collection throughout the study.

Treatment:

Procedure: Cryosurgery

Procedure: Biospecimen Collection

Procedure: Computed Tomography

Procedure: Chest Radiography

Procedure: Bronchoscopy with Biopsy

Other: Electronic Health Record Review

Procedure: Resection

Procedure: Robotic Bronchoscopy