RecruitingRecruiting
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
NCT06593106 · Vanderbilt-Ingram Cancer Center
In plain English
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Official title
The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
About this study
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 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.
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
Study design
Enrollment target: 30 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-27
Estimated completion: 2026-08-31
Last updated: 2026-02-02
Interventions
Procedure: CryosurgeryProcedure: Robotic BronchoscopyProcedure: Bronchoscopy with BiopsyProcedure: ResectionProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Biospecimen CollectionOther: Electronic Health Record Review
Primary outcomes
- • Maximum tolerated dose for cryodevitalization cycle duration (At time of surgery)
- • Feasibility of bronchoscopically delivered cryodevitalization (At time of surgery)
- • Incidence of adverse events (Up to 7 days post-cryosurgery)
Sponsor
Vanderbilt-Ingram Cancer Center · other
With: National Cancer Institute (NCI), Swim Across America
Contacts & investigators
ContactVanderbilt-Ingram Services for Timely Access · contact · cip@vumc.org · 800-811-8480
InvestigatorFabien Maldonado, MD · principal_investigator, Vanderbilt University/Ingram Cancer Center
All locations (1)
Vanderbilt University/Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States