Liver MetastasesNCT04404647
Irreversible Electroporation of Unresectable Liver Tumors
A study testing Irreversible electroporation in people with Liver Metastases and Hepatocellular Carcinoma, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Hepatocellular Carcinoma, Bile Duct Cancer
- What is being tested?
- Irreversible electroporation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gastrointestinal Surgery, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
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.
Read the 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.
- Conditions
- Liver Metastases, Hepatocellular Carcinoma, Bile Duct Cancer
- Being tested
- Irreversible electroporation
- Keywords
- irreversible electroporation, primary liver cancer, secondary liver cancer, colorectal liver metastases, NanoKnife, ablation, IRE
- Medical subject headings
- Carcinoma, Hepatocellular, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporationProcedure or surgery
Also called NanoKnife(TM)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation. Receives: Procedure: Irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day complication rate and severity
Adverse events will be registered and scaled according to the Clavien-Dindo classification.
Measured: 90 days after intervention (last patient)
Secondary outcomes (9)
Technical success rate
The rate of patients were it is possible to place needles according to the treatment plan and deliver 90 electrical pulses per electrode pair
Measured: 90 days after intervention (last patient)
Technical efficacy rate (1 month) (according to SIR)
The rate of patients showing no residual tumor on contrast enhanced computed tomography (ceCT)
Measured: 90 days after intervention (last patient)
Median local progression free survival from IRE
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).
Measured: 2 years after intervention (last patient)
Median overall survival (OS) from IRE
The median time from the intervention to death.
Measured: 2 years after intervention (last patient)
Longitudinal changes in perceived quality of life
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.
Measured: 2 years after intervention (last patient)
Longitudinal changes in pain perception
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).
Measured: 2 years after intervention (last patient)
Periprocedural pain perception
Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).
Measured: 90 days after intervention (last patient)
Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status
Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" performance status scale (range 0 - 5, low score is better)
Measured: 2 years after intervention (last patient)
Longitudinal changes in nutritional status assessment
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).
Measured: 2 years after intervention (last patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
- Investigators
- Ole Thorlacius-Ussing, Professor, DMSc, Study director, Department of Gastrointestinal Surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404647
- Sponsor's protocol ID
- N-20190072
- Status last verified
- Mar 2021
- First submitted
- 15 May 2020
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility
- ClinicalTrials.gov ID
- NCT04404647
- Acronym / sponsor ID
- N-20190072
- Conditions
- Liver Metastases, Hepatocellular Carcinoma, Bile Duct Cancer
- Keywords
- irreversible electroporation, primary liver cancer, secondary liver cancer, colorectal liver metastases, NanoKnife, ablation, IRE
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low accrual rate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of SurgeryUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Irreversible electroporationSelected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irreversible electroporationAlso: NanoKnife(TM)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. | Procedure or surgery | Intervention |
Primary outcome
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.
9 secondary outcomes
Technical success rate
Time frame: 90 days after intervention (last patient)
Technical efficacy rate (1 month) (according to SIR)
Time frame: 90 days after intervention (last patient)
Median local progression free survival from IRE
Time frame: 2 years after intervention (last patient)
Median overall survival (OS) from IRE
Time frame: 2 years after intervention (last patient)
Longitudinal changes in perceived quality of life
Time frame: 2 years after intervention (last patient)
Longitudinal changes in pain perception
Time frame: 2 years after intervention (last patient)
Periprocedural pain perception
Time frame: 90 days after intervention (last patient)
Longitudinal changes in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: 2 years after intervention (last patient)
Longitudinal changes in nutritional status assessment
Time frame: 2 years after intervention (last patient)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Thorlacius-Ussing, Professor, DMSc study director
Department of Gastrointestinal Surgery, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irreversible electroporation in people with Liver Metastases and Hepatocellular Carcinoma, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day complication rate and severity (time frame: 90 days after intervention (last patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.