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| Name | Class |
|---|---|
| William M. Wood Foundation | UNKNOWN |
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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...
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-guided Percutaneous Cryoablation of Lung Tumor | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 years |
| Radiologic Response Rate Of Cryoablation | The number of participants that achieve a complete response (CR) or partial response (PR) following cryoablation.
| 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan J Mooradian, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39191779 | Derived | Mooradian MJ, Fintelmann FJ, LaSalle TJ, Simon J, Graur A, Muzikansky A, Mino-Kenudson M, Shalhout S, Kaufman HL, Jenkins RW, Lawrence D, Lawless A, Sharova T, Uppot RN, Fang J, Blaum EM, Gonye ALK, Gushterova I, Boland GM, Azzoli C, Hacohen N, Sade-Feldman M, Sullivan RJ. Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial. Nat Commun. 2024 Aug 27;15(1):7357. doi: 10.1038/s41467-024-51722-x. |
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| Biopsy | Procedure | Removing a small piece of the affected area to confirm cancer |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D008919 | Investigative Techniques |
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