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Irreversible Electroporation of Unresectable Liver Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404647
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

Brief Summary:
The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts.

Condition or disease Intervention/treatment Phase
Liver Metastases Hepatocellular Carcinoma Bile Duct Cancer Procedure: Irreversible electroporation Not Applicable

Detailed Description:

Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other established liver directed therapies.

Prior to inclusion all potential participant will be evaluated by the local multidisciplinary team, to insure fulfillment of the above-mentioned criteria. In general, the included patient will have tumors with <1 cm of margin to major hepatic vessels or bile ducts, thereby not allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract damage, liver failure or ineffective ablation due to heat sink.

IRE will be done under general anesthesia as an in-patient procedure. Patients will be observed for at least 24 hours after IRE.

Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up period, patients will be asked to fill out electronic forms monitoring pain, quality of life and nutritional status. After 24 months the patients will only be followed with CT scans in accordance with the mentioned schedule. Data collection for scientific purposes will stop when the last included patient has been followed for at least 24 months or when the study period concludes.

In case of multiple liver tumors, where a conventional treatment approach is not possible due to a single lesion being too close to major vessels or bile ducts, IRE may be used in conjunction to conventional therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : March 30, 2025
Estimated Study Completion Date : March 30, 2025


Arm Intervention/treatment
Experimental: Intervention
Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.
Procedure: Irreversible electroporation
The IRE procedure will be carried out as ultrasound guided technique either percutaneously or during laparotomy. Needle spacing and electrical pulse delivery will be performed in a standardized way.
Other Name: NanoKnife(TM)




Primary Outcome Measures :
  1. 90-day complication rate and severity [ Time Frame: 90 days after intervention (last patient) ]
    Adverse events will be registered and scaled according to the Clavien-Dindo classification.


Secondary Outcome Measures :
  1. Technical success rate [ Time Frame: 90 days after intervention (last patient) ]
    The rate of patients were it is possible to place needles according to the treatment plan and deliver 90 electrical pulses per electrode pair

  2. Technical efficacy rate (1 month) (according to SIR) [ Time Frame: 90 days after intervention (last patient) ]
    The rate of patients showing no residual tumor on contrast enhanced computed tomography (ceCT)

  3. Median local progression free survival from IRE [ Time Frame: 2 years after intervention (last patient) ]
    The median time from the intervention to progressive disease of the treated lesion, according to RECIST 1.1 or modified RECIST (mRECIST) (only for HCC).

  4. Median overall survival (OS) from IRE [ Time Frame: 2 years after intervention (last patient) ]
    The median time from the intervention to death.

  5. Longitudinal changes in perceived quality of life [ Time Frame: 2 years after intervention (last patient) ]
    Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial will be calculated separately.

  6. Longitudinal changes in pain perception [ Time Frame: 2 years after intervention (last patient) ]
    Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).

  7. Periprocedural pain perception [ Time Frame: 90 days after intervention (last patient) ]
    Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).

  8. Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: 2 years after intervention (last patient) ]
    Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" performance status scale (range 0 - 5, low score is better)

  9. Longitudinal changes in nutritional status assessment [ Time Frame: 2 years after intervention (last patient) ]
    Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37, low score is better).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary or secondary cancer of the liver.
  • Largest tumor diameter ≤5 cm in any plane.
  • Tumor must be deemed as unresectable and unsuitable for other established curative liver directed therapies.
  • Treatment must be given with curative intent.
  • Patients must be able to give informed consent.

Exclusion Criteria:

  • Radiological signs of synchronous intra- or extrahepatic disease, unless curative intended therapy is planned.
  • Tumor is inaccessible e.g. due to venous dilation etc. (assessed with preoperative ultrasound)
  • American Society of Anesthesiologists (ASA) score >3
  • Eastern Cooperative Oncology Group (ECOG) performance status >2
  • Child-Pugh class C
  • International Normalized Ratio (INR)>1.5
  • Pregnancy
  • Persistent atrial fibrillation
  • Implanted electronic devices e.g. cardiac pacemakers or other electrostimulators.
  • Metal stents or other metallic objects near the ablation zone (unless the stent can be replaced with a plastic stent prior to IRE)
  • Severe allergies to anesthetic agent, paralytic agent or any of the equipment used during treatment.
  • Patient is referred from a hospital outside of Denmark

Information from the National Library of Medicine

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): NCT04404647


Contacts
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Contact: Rasmus Virenfeldt Flak, MD +4597661181 rasmus.virenfeldt@rn.dk
Contact: Mogens Tornby Stender, MD, PhD +4597661761 mogens.stender@rn.dk

Locations
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Denmark
Department of Gastrointestinal Surgery, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Rasmus Virenfeldt Flak, MD    +4597661181    rasmus.virenfeldt@rn.dk   
Sponsors and Collaborators
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Investigators
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Study Director: Ole Thorlacius-Ussing, Professor, DMSc Department of Gastrointestinal Surgery, Aalborg University Hospital
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Responsible Party: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Professor of surgery, Consultant surgeon, DMSc, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT04404647    
Other Study ID Numbers: N-20190072
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital:
irreversible electroporation
primary liver cancer
secondary liver cancer
colorectal liver metastases
NanoKnife
ablation
IRE
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bile Duct Neoplasms
Cholangiocarcinoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Neoplasms
Bile Duct Diseases
Carcinoma, Hepatocellular
Neoplastic Processes
Pathologic Processes
Adenocarcinoma
Carcinoma
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases