Liver CancerPhase 1/2NCT00514930
Multicentre Prospective Clinical Trial for RFA Tumour Aspirator Treatment of Primary and Secondary Malignancies of the Liver
A Phase 1/2 study testing Hexablate in people with Liver Cancer, run by University of Thessaly at 1 site in Greece.
Trial summary
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Hexablate
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteGreece
- Study dates
- Feb 2007to Aug 2007
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Eligible participants will be 18 years and older.
- Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location.
- Study specific signed informed consent will also have to be completed to allow patient inclusion.
Who cannot join
- Age younger than 18 years old
- Pregnant women
- Uncorrectable coagulopathy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
C. Hatzitheofilou
Larissa, 41110
Dimitris Zacharoulis, Assistant Professor, +30-2410-682730 ext. 2730, zachadim@yahoo.com
Ahmet Ayav, M.D.
About this study
Official title: A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours
Read the detailed description
Patients with unresectable primary or secondary malignancies of the liver have limited treatment options which often only give a small survival benefit. RFA has been demonstrated to be effective in local tumour eradication and to extend patient survival. In this study RFA aspiration will be used to treat unresectable primary or secondary tumours of the liver. RFA will be used to develop a shell of tissue destruction around the tumour, with aspiration removing tissue and fluid from the centre of the lesion. The potential advantages of aspirating during ablation could be to reduce aerosol spread of tumour within the liver parenchyma and peritoneum. Additionally, aspirating the ablated tissue may reduce the incidence of systemic side effects related to RFA when larger lesions are treated. This study would establish the safety and efficiacy of RFA aspiration in the treatment of unresectable primary/secondary malignancies of the liver.
This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primary/secondary malignancies of the liver, which are not suitable for formal liver resection. The basis for unresectability being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA>3), bilobar disease and anatomical location. Early and late complications relating to the usage of the RFA aspirator will be analysed. Additionally, local recurrence and long term survival will be assessed. If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality. Then these initial results will justify further in depth studies to establish its clinical role.
II. SPECIFIC AIMS/OBJECTIVES
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours.
III. STUDY OVERVIEW
It is anticipated that 100-200 participants will be recruited. The time period for patient recruitment will be for 2 years with follow up for 3 years. The total study period will be 5 years in order to allow the assessment of complications, local ablation success and survival benefit.
- Conditions
- Liver Cancer
- Being tested
- Hexablate
- Keywords
- radiofrequency ablation, liver cancer, complications, liver tumors
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexablateDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.
Measured: 2 years
Secondary outcomes (1)
Complications and unexpected adverse events (early and late) related to RFA aspirator treatment to be assessed. Data points to be collected as per proforma for trial.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startFeb 2007
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Investigators
- Dimitris Zacharoulis, M.D., Principal investigator, University of ThessalyNagy Habib, Professor, Study chair, Imperial College London U.K.Giuseppe Navarra, Professor, Study director, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514930
- Sponsor's protocol ID
- Multicenter hexablate protocol
- Status last verified
- Aug 2007
- First submitted
- 9 Aug 2007
- Last updated
- 10 Aug 2007
- Results posted
- No
Publications
Zacharoulis D, Khorsandi SE, Vavra P, Dostalik J, Navarra G, Nicholls JP, Jiao LR, Habib NA. Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers. Liver Int. 2009 Jul;29(6):824-30. doi: 10.1111/j.1478-3231.2008.01910.x.
PubMed 19638109
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Clinical Trial of a New Bipolar Radiofrequency Ablation/Aspirator Device (Hexablate) in the Management of Primary and Secondary Liver Cancers
- ClinicalTrials.gov ID
- NCT00514930
- Acronym / sponsor ID
- Multicenter hexablate protocol
- Conditions
- Liver Cancer
- Keywords
- radiofrequency ablation, liver cancer, complications, liver tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Aug 2007 (estimated)
- First posted
- 10 Aug 2007 (estimated)
- 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 primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours
Detailed description
Patients with unresectable primary or secondary malignancies of the liver have limited treatment options which often only give a small survival benefit. RFA has been demonstrated to be effective in local tumour eradication and to extend patient survival. In this study RFA aspiration will be used to treat unresectable primary or secondary tumours of the liver. RFA will be used to develop a shell of tissue destruction around the tumour, with aspiration removing tissue and fluid from the centre of the lesion. The potential advantages of aspirating during ablation could be to reduce aerosol spread of tumour within the liver parenchyma and peritoneum. Additionally, aspirating the ablated tissue may reduce the incidence of systemic side effects related to RFA when larger lesions are treated. This study would establish the safety and efficiacy of RFA aspiration in the treatment of unresectable primary/secondary malignancies of the liver.
This protocol is for a prospective multi-centre clinical trial of the use of RFA aspiration in the treatment of patients with primary/secondary malignancies of the liver, which are not suitable for formal liver resection. The basis for unresectability being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA>3), bilobar disease and anatomical location. Early and late complications relating to the usage of the RFA aspirator will be analysed. Additionally, local recurrence and long term survival will be assessed. If the use of the RFA aspirator produces improved survival with minimal morbidity and mortality. Then these initial results will justify further in depth studies to establish its clinical role.
II. SPECIFIC AIMS/OBJECTIVES
The primary aim for this trial is to assess whether the RFA aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours.
III. STUDY OVERVIEW
It is anticipated that 100-200 participants will be recruited. The time period for patient recruitment will be for 2 years with follow up for 3 years. The total study period will be 5 years in order to allow the assessment of complications, local ablation success and survival benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible participants will be 18 years and older.
- Have unresectable primary/secondary malignant tumours of the liver. Unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (ASA 3), bilobar disease and anatomical location.
- Study specific signed informed consent will also have to be completed to allow patient inclusion.
Key exclusion criteria (3 listed)
- Age younger than 18 years old
- Pregnant women
- Uncorrectable coagulopathy
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 |
|---|---|---|
| Hexablate | Device | – |
Primary outcome
To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival.
Time frame: 2 years
1 secondary outcome
Complications and unexpected adverse events (early and late) related to RFA aspirator treatment to be assessed. Data points to be collected as per proforma for trial.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
- Derived from this study: PubMed 19638109Zacharoulis D, Khorsandi SE, Vavra P, Dostalik J, Navarra G, Nicholls JP, Jiao LR, Habib NA. Pilot study for a new bipolar radiofrequency ablation/aspirator device in the management of primary and secondary liver cancers. Liver Int. 2009 Jul;29(6):824-30. doi: 10.1111/j.1478-3231.2008.01910.x.
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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.
Dimitris Zacharoulis, M.D. principal investigator
University of Thessaly
Nagy Habib, Professor study chair
Imperial College London U.K.
Giuseppe Navarra, Professor study director
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hexablate in people with Liver Cancer, run by University of Thessaly at 1 site in Greece.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Aug 2007. 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 Greece. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitris Zacharoulis, Assistant Professor (+30-2410-682803, zachadim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the local and remote intra-hepatic and extra-hepatic recurrence rates and their impact on survival. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514930, which also lists 1 linked publication.
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 10 Aug 2007.