NCT06593106Active, not recruiting
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 5 Sept 2024
- Start date
- 27 Sept 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT06593106
What you commit to
- Study type: Interventional
- Participants enrolled: 13
- From 27 Sept 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with medical comorbidities deemed high-risk for surgical resection
Other illness
- 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 endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
- Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg)
Lab values
- Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5
- Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Other
- Patients with an expected survival less than 6 months
- Pregnant women
- Inability to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.