Immunological Response After Ablative Therapy in the Liver (IRAL)
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|ClinicalTrials.gov Identifier: NCT03040453|
Recruitment Status : Withdrawn (poor recruitment)
First Posted : February 2, 2017
Last Update Posted : November 30, 2020
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).
Previous studies have shown effects on the immune system after ablative therapies.
The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Immune Response||Device: Microwave ablation Device: Irreversible electroporation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||September 30, 2018|
20 patients will be treated with microwave ablation
Device: Microwave ablation
20 patients will be treated with irreversible electroporation
Device: Irreversible electroporation
Other Name: Nano Knife, Angiodynamics
- Immunological response [ Time Frame: Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90 ]Change in immunological response
- Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months. [ Time Frame: Follow-up every three months for one year with CT scan. ]Compare the effect of the two different ablative methods
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040453
|Department of Surgery and Urology, Danderyd Hospital|
|Stockholm, Sweden, 18288|
|Principal Investigator:||Jacob Freedman, MD, PhD||Karolinska Instituet|