Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
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.
Lung
N/A
Adults
Not Available
Not Available
Maldonado, Fabien
Local
Vanderbilt University
09-27-2024
Eligibility
18 Years and older
ALL
false
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
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
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
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
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
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 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 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 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 with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] > 50mmHg)
Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Patients with medical comorbidities deemed high-risk for surgical resection
Patients with medical comorbidities deemed high-risk for surgical resection
Pregnant women
Pregnant women
Inability to provide informed consent
Inability to provide informed consent
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
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
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
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
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
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 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 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 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 with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] > 50mmHg)
Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Patients with medical comorbidities deemed high-risk for surgical resection
Patients with medical comorbidities deemed high-risk for surgical resection
Pregnant women
Pregnant women
Inability to provide informed consent
Inability to provide informed consent
