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Immunological Response After Ablative Therapy in the Liver (IRAL)

Primary Purpose

Hepatocellular Carcinoma, Immune Response

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Microwave ablation
Irreversible electroporation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatocellular Carcinoma focused on measuring Irreversible electroporation, Microwave ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery and Urology, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Microwave ablation

Irreversible electroporation

Arm Description

20 patients will be treated with microwave ablation

20 patients will be treated with irreversible electroporation

Outcomes

Primary Outcome Measures

Immunological response
Change in immunological response

Secondary Outcome Measures

Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
Compare the effect of the two different ablative methods

Full Information

First Posted
January 20, 2017
Last Updated
November 26, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03040453
Brief Title
Immunological Response After Ablative Therapy in the Liver
Acronym
IRAL
Official Title
Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
poor recruitment
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Immune Response
Keywords
Irreversible electroporation, Microwave ablation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microwave ablation
Arm Type
Other
Arm Description
20 patients will be treated with microwave ablation
Arm Title
Irreversible electroporation
Arm Type
Other
Arm Description
20 patients will be treated with irreversible electroporation
Intervention Type
Device
Intervention Name(s)
Microwave ablation
Intervention Type
Device
Intervention Name(s)
Irreversible electroporation
Other Intervention Name(s)
Nano Knife, Angiodynamics
Primary Outcome Measure Information:
Title
Immunological response
Description
Change in immunological response
Time Frame
Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Secondary Outcome Measure Information:
Title
Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.
Description
Compare the effect of the two different ablative methods
Time Frame
Follow-up every three months for one year with CT scan.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Freedman, MD, PhD
Organizational Affiliation
Karolinska Instituet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery and Urology, Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immunological Response After Ablative Therapy in the Liver

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