Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-01-20 @ 3:30 PM
Study NCT ID:
NCT06593106
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D001999', 'term': 'Bronchoscopy'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-20', 'size': 773006, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-06T10:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-02', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose for cryodevitalization cycle duration', 'timeFrame': 'At time of surgery', 'description': '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.'}, {'measure': 'Feasibility of bronchoscopically delivered cryodevitalization', 'timeFrame': 'At time of surgery', 'description': 'Proportion of procedures that can be safely completed with full dose delivered'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 7 days post-cryosurgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pathologic response', 'timeFrame': 'At time of surgical resection', 'description': 'Pathologic response will be assessed comparing the confirmed devitalization zone determined by intraprocedural cone-beam computed tomography imaging (percent tumor treated by cryodevitalization) and remaining tumor viability by histopathologic examination of resected specimens.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'From day 8 post-cryosurgery to surgical resection', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage I Lung Cancer', 'Stage II Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n* 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\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* 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\n* Patients with an expected survival less than 6 months\n* Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways\n* Patients with medically uncorrectable coagulopathy: abnormal platelet count \\< 100 × 10\\^9/L or an international normalized ratio \\> 1.5\n* Patients with known pulmonary hypertension (PASP \\[pulmonary artery systolic pressure\\] \\> 50mmHg)\n* Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors\n* Patients with medical comorbidities deemed high-risk for surgical resection\n* Pregnant women\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06593106', 'briefTitle': 'Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer', 'orgStudyIdInfo': {'id': 'VICC-VCTHO24099'}, 'secondaryIdInfos': [{'id': 'NCI-2024-07299', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}, {'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '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 x-ray on study as well as CT and tissue sample collection throughout the study.', 'interventionNames': ['Procedure: Cryosurgery', 'Procedure: Robotic Bronchoscopy', 'Procedure: Bronchoscopy with Biopsy', 'Procedure: Resection', 'Procedure: Chest Radiography', 'Procedure: Computed Tomography', 'Procedure: Biospecimen Collection', 'Other: Electronic Health Record Review']}], 'interventions': [{'name': 'Cryosurgery', 'type': 'PROCEDURE', 'description': 'Undergo cryodevitalization', 'armGroupLabels': ['Treatment']}, {'name': 'Robotic Bronchoscopy', 'type': 'PROCEDURE', 'description': 'Undergo standard of care robotic bronchoscopy with biopsy', 'armGroupLabels': ['Treatment']}, {'name': 'Bronchoscopy with Biopsy', 'type': 'PROCEDURE', 'description': 'Undergo standard of care robotic bronchoscopy with biopsy', 'armGroupLabels': ['Treatment']}, {'name': 'Resection', 'type': 'PROCEDURE', 'description': 'Undergo standard of care surgical resection', 'armGroupLabels': ['Treatment']}, {'name': 'Chest Radiography', 'type': 'PROCEDURE', 'description': 'Undergo chest x-ray', 'armGroupLabels': ['Treatment']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'description': 'Undergo Computed Tomography', 'armGroupLabels': ['Treatment']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo tissue sample collection', 'armGroupLabels': ['Treatment']}, {'name': 'Electronic Health Record Review', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanderbilt-Ingram Service for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}, {'name': 'Fabien Maldonado, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Vanderbilt-Ingram Services for Timely Access', 'role': 'CONTACT', 'email': 'cip@vumc.org', 'phone': '800-811-8480'}], 'overallOfficials': [{'name': 'Fabien Maldonado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University/Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Swim Across America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Thoracic Surgery', 'investigatorFullName': 'Fabien Maldonado', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}