Clinical trial · Interventional
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
NCT06593106CI-TRIAL-00122592active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Bronchoscopy with Biopsy | Procedure | — | UNRESOLVED |
| Chest Radiography | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Cryosurgery | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
| Robotic Bronchoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- 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
Primary outcomes (3)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.