Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
NCT ID: NCT06593106
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-09-27
2026-08-31
Brief Summary
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Detailed Description
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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 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.
After 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
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.
Cryosurgery
Undergo cryodevitalization
Robotic Bronchoscopy
Undergo standard of care robotic bronchoscopy with biopsy
Bronchoscopy with Biopsy
Undergo standard of care robotic bronchoscopy with biopsy
Resection
Undergo standard of care surgical resection
Chest Radiography
Undergo chest x-ray
Computed Tomography
Undergo Computed Tomography
Biospecimen Collection
Undergo tissue sample collection
Electronic Health Record Review
Ancillary studies
Interventions
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Cryosurgery
Undergo cryodevitalization
Robotic Bronchoscopy
Undergo standard of care robotic bronchoscopy with biopsy
Bronchoscopy with Biopsy
Undergo standard of care robotic bronchoscopy with biopsy
Resection
Undergo standard of care surgical resection
Chest Radiography
Undergo chest x-ray
Computed Tomography
Undergo Computed Tomography
Biospecimen Collection
Undergo tissue sample collection
Electronic Health Record Review
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Swim Across America
OTHER
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Fabien Maldonado
Professor of Medicine, Thoracic Surgery
Principal Investigators
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Fabien Maldonado, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2024-07299
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC-VCTHO24099
Identifier Type: -
Identifier Source: org_study_id
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