An interventional study of Cryoablation and Biopsy in Lung Cancer, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
This research study is studying cryoablation (a treatment to kill cancer cells with extreme cold) combined with continued treatment with current immune checkpoint inhibitor as a possible treatment for lung cancer.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has approved each aspect of this therapy, however this research study is unique because it combines them as a treatment option for the participant's disease. That has not been approved by the FDA.
In this research study, The investigators are...
Exclusion Criteria:
* Image-guided core needle biopsy to confirm cancer will be perform * Patients will undergo cryoablation as a standard procedure * cryoablation will be performed with a three-cycle freeze-thaw phase protocol * Non-contrast CT images will be obtained in 3 to 5 minutes intervals to visualize the evolving ablation zone
Procedure: Cryoablation · Procedure: Biopsy
This involves passing a special needle into the body (cryoprobe) to freeze tumor and kill a small part (not all) of the cancer. The immune system will respond to the damage caused by freezing part of the tumor.
Removing a small piece of the affected area to confirm cancer
Cumulative Incidence of Treatment Related Serious Adverse Events
The safety and feasibility of the procedure will be determined based on observed adverse events. Cryoablation will be determined safe and feasible to implement in this study population if the cumulative incidence of serious adverse events (SAE) related to cryoablation is no higher than 20%. Adverse events are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time frame: 2 years
Radiologic Response Rate Of Cryoablation
The number of participants that achieve a complete response (CR) or partial response (PR) following cryoablation. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital