- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040453
Immunological Response After Ablative Therapy in the Liver (IRAL)
Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden, 18288
- Department of Surgery and Urology, Danderyd Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
- Physically fit to undergo general anaesthesia
- Fully understand swedish instructions regarding the study
Exclusion Criteria:
- Atrial fibrillation (for irreversible electroporation)
- Pacemaker (for irreversible electroporation)
- >3 lesions
- > 30 mm in any cross section diameter
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Microwave ablation
20 patients will be treated with microwave ablation
|
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Other: Irreversible electroporation
20 patients will be treated with irreversible electroporation
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Follow-up every three months for one year with CT scan.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacob Freedman, MD, PhD, Karolinska Instituet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPN 2016/2212-31/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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