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

NCT ID: NCT06593106Sponsor: Vanderbilt-Ingram Cancer CenterLast updated: 2026-02-02

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.

Arms & 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

    Undergo tissue sample collection

  • OtherElectronic Health Record Review

    Ancillary studies

Outcome measures

Primary

  • Maximum tolerated dose for cryodevitalization cycle duration

    Will implement a modified Toxicity Probability Interval design. Each dose will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

    Time frame: At time of surgery

  • Feasibility of bronchoscopically delivered cryodevitalization

    Proportion of procedures that can be safely completed with full dose delivered

    Time frame: At time of surgery

  • Incidence of adverse events

    Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

    Time frame: Up to 7 days post-cryosurgery

Secondary

  • Pathologic response

    Time frame: At time of surgical resection

  • Incidence of adverse events

    Time frame: From day 8 post-cryosurgery to surgical resection

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 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

Study locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203

Recruiting
Vanderbilt-Ingram Service for Timely Access · Contact
800-811-8480cip@vumc.org
Fabien Maldonado, MD · Principal Investigator
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial | Cancerify