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CRYSTAL Trial: Cryodevitalization for Early Stage Lung Cancer

This study, called the CRYSTAL Trial, is looking at a treatment called cryodevitalization for people with early-stage (Stage I or Stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a special probe to freeze and destroy cancer cells. This treatment is given during a standard robotic bronchoscopy (a procedure where a thin tube is inserted into your airways to look at your lungs and take tissue samples). Researchers want to find out the best amount of time to use cryodevitalization and if it's safe and effective. You might be able to join if you have a single lung nodule (a small growth) that is less than or equal to three centimeters and confirmed to be cancer. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a dose-escalation study, meaning different treatment times for cryodevitalization will be tested. It plans to enroll 30 participants.
What's involved
You would undergo cryodevitalization during a robotic bronchoscopy with biopsy, followed by standard surgical removal of the tumor. You would also have chest x-rays, CT scans, and tissue samples collected.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would have follow-up appointments at 3 and 7 days, and then as needed for 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06593106

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Vanderbilt-Ingram Cancer Center
~13 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:CryosurgeryRobotic BronchoscopyBronchoscopy with BiopsyResectionChest RadiographyComputed Tomography

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose for cryodevitalization cycle duration
Measured over At time of surgery
+2 more outcomes measured

Conditions

Stage I Lung Cancer
Stage II Lung Cancer

Explore related trials

Lung Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Fabien Maldonado, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Maximum tolerated dose for cryodevitalization cycle durationAt time of surgery

    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.

  • Feasibility of bronchoscopically delivered cryodevitalizationAt time of surgery

    Proportion of procedures that can be safely completed with full dose delivered

  • Incidence of adverse eventsUp to 7 days post-cryosurgery

    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.