Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
131 participants
INTERVENTIONAL
2014-04-10
2018-08-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
NCT01307501
Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
NCT04339218
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
NCT02511678
Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
NCT01461252
Radiotherapy or Observation of Liver Metastases in Small Cell Lung Cancer
NCT05150145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cryoablation
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. Tumors in both lungs are to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session will not be performed. All participants will receive cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors are to be completed within an 8-week window.
Cryoablation
Application of extremely cold temperatures to the identified tumor(s).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cryoablation
Application of extremely cold temperatures to the identified tumor(s).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant has signed a written informed consent.
* Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy; or Participant presents with Stage 4 pulmonary metastatic disease previously confirmed on imaging (for example, computerized tomography or CT) with histology proven primary cancer.
* Participant has up to 6 local pulmonary metastases targetable by cryoablation.
* Targeted index tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm, measured in the longest cross-sectional dimension.
* The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than 0.5 cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
* Karnofsky Performance Scale (KPS) score greater than or equal to 60.
* Platelet count greater than 50,000/millimeters (mm)\^3 within 8 weeks prior to initial cryoablation procedure.
* International Normalized Ratio (INR) less than 1.5 within 8 weeks prior to initial cryoablation procedure.
* Participant has a life expectancy of greater than 3 months.
Exclusion Criteria
* Participant has uncontrollable primary or metastatic disease outside of the lung.
* Participant is unable to lie flat or has respiratory distress at rest.
* Participant has a coagulopathy or bleeding disorder which is uncontrolled.
* Absolute Neutrophil Count (ANC) \<1000 within 8 weeks prior to initial cryoablation procedure.
* 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 (for example, experimental chemotherapy regimen).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thierry de Baere, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Matthew Callstrom, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Cancer Treatment Centers of America at Southeastern Regional Medical Center
Newnan, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Medical Center
New York, New York, United States
State University of New York at Stony Brook
Stony Brook, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Inova Alexandria Hospital CVIR
Alexandria, Virginia, United States
Institut Bergonié
Bordeaux, Aquitaine, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015.
Ahmed 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.
Kawamura 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.
Asimakopoulos 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.
Wang 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.
Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20.
Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9.
Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CUC13-LNG079
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.