Cryodevitalization treatment for early stage lung cancer
The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
This study is testing a freezing treatment for early stage lung cancer to see how well it works and what the best dose is for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06593106 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of cryodevitalization, a cryosurgery technique, for treating patients with early stage lung cancer (stage I or II). The approach involves using a flexible cryoprobe to freeze and kill tumor cells during standard robotic bronchoscopy. The study aims to determine the maximum tolerated dose of cryodevitalization through a dose-escalation methodology, where patients undergo multiple freeze-thaw cycles. Following treatment, patients will be monitored for side effects and outcomes over a period of 24 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with a single malignant pulmonary nodule less than or equal to three centimeters, located in the outer two-thirds of the lung, and who require a biopsy prior to surgical resection.
Not a fit: Patients with nodules that are not accessible for cryodevitalization or those with mediastinal involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for patients with early stage lung cancer, potentially improving outcomes and reducing the need for more extensive surgeries.
How similar studies have performed: While cryosurgery has been explored in various contexts, this specific application for early stage lung cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Fabien Maldonado, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Services for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.