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

Launched by VANDERBILT-INGRAM CANCER CENTER · Sep 9, 2024

Keywords

ClinConnect Summary

The CRYSTAL Trial is studying a treatment called cryodevitalization for patients with early-stage lung cancer, specifically those with stage I or stage II. Cryodevitalization is a procedure that uses extreme cold to freeze and kill cancer cells, and it is performed during a special type of lung examination called robotic bronchoscopy. The trial aims to understand the side effects of this treatment and determine the best timing for its use in the care of patients with small lung tumors.

To participate in the trial, patients must be at least 18 years old and have a single lung nodule (a small growth) that is less than 2 centimeters in size and confirmed as lung cancer during the procedure. The nodules should be located in the outer parts of the lung and not too close to major blood vessels or other important structures. Participants can expect to receive this experimental treatment in conjunction with standard care, and the trial is currently looking for volunteers. It's important to know that certain health conditions or treatments may make someone ineligible for the trial, such as having serious bleeding problems or being pregnant.

Gender

ALL

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