Status:
RECRUITING
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Swim Across America
Conditions:
Stage I Lung Cancer
Stage II Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cryosurg...
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 cryodevi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06593106
Start Date
September 27 2024
End Date
August 31 2026
Last Update
November 4 2025
Active Locations (1)
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1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37203