Clinical trial · Interventional
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Evaluating Cryoablation of Metastatic Lung/Pleura Tumors in Patients - Safety and Efficacy
NCT01307501CI-TRIAL-00052766ECLIPSEcompletedN/AResults postedClinicalTrials.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)
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cryoablation
- description
- Participants will undergo a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. No more than 3 tumors in 1 lung can be treated in a single session, and no more than 5 total lung tumors (across both lungs) can be treated during the study.
- interventionNames
- Device: Cryoablation
Primary outcomes (1)
- measure
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
- timeFrame
- Baseline and Month 60
- description
- Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must be at least 18 years old. * Participant has signed a written informed consent. * Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease. * Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally. * Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm. * The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures. * Eastern Cooperative Oncology Group (ECOG) score of 0-2. * Karnofsky Performance Scale (KPS) score ≥60. * Platelet count \>50,000/cubed millimeters (mm\^3) within 60 days prior to study treatment. * International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment. * Participant has a life expectancy of \>3 months. * Participant is clinically suitable for cryoablation procedure. Exclusion Criteria: * Participant's primary cancer is lung cancer. * Participant is unable to lie flat or has respiratory distress at rest. * Participant has uncontrolled coagulopathy or bleeding disorders. * Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure. * Participant has a history of an allergic reaction to iodine injections or to shellfish. * Participant has evidence of active systemic, pulmonary, or pericardial infection. * Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up. * Participant is currently participating in other experimental studies that could affect the primary endpoint.
References
Publications (7)
- BACKGROUNDGillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015. PMID 18442957
- BACKGROUNDAhmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6. doi: 10.2214/AJR.04.1068. No abstract available. PMID 16714662
- BACKGROUNDAsimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14. doi: 10.1378/chest.127.6.2007. PMID 15947313
- BACKGROUNDKawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051. PMID 16678583
- BACKGROUNDWang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98. doi: 10.1148/radiol.2351030747. PMID 15798173
- BACKGROUNDBlazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006 Jul 1;24(19):3178-86. doi: 10.1200/JCO.2005.05.2951. PMID 16809741
- BACKGROUNDWare J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. PMID 8628042