Hepatocellular CancerARMTICHNCT01486134
Major RF Ablations of Hepatomas Under MR Thermometry Monitoring
A study testing Multipolar Radiofrequency ablation in people with Hepatocellular Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Object of the study: To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Multipolar Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2012to 20 Dec 2016
- 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
- Patient of 18 year old.
- Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
- Proof of underlying cirrhosis.
- Multidisciplinary decision of RF ablation treatment
- Informed consent of patient
- Available healthcare insurance
Who cannot join
- Patient with short term life training uncontrollable disease
- Pregnancy
- Follow up Impossible
- Contra indication for general anesthesia
- Contra indication for MR examination with gadolinium injection
- Tumor located at less than 10 mm from colonic wall or main biliary tract
Show all 17Show fewer
- Tumor invisible on MR examination
- Absence of safe percutaneous course to puncture the tumor
- Child - Pugh B or C cirrhosis
- Abundant ascites
- PROTHROMBIN activity < 50 %
- Platelet count < 40 .10 3/ml
- Antecedent of ascitis decompensation
- Severe portal hypertension defined by the presence of large oesophageal variceal (grade 2) , of radiological ascitis or umbilical vein repermeabilisation
- Elevation of transaminases (>3 upper limit normal range)
- Antecedent of biliodigestive anastomosis
- Antecedent of endoscopic sphincterotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Real Time MR Temperature Monitoring of Multipolar Radiofrequency Ablation of Large Hepatocellular Carcinomas (≥ 5 CM)-ARMTICH STUDY
Object of the study:
To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors.
Read more
Experimental plan :
This pilot study consist to perform in a single center a single procedure of the multipolar RF ablation under MR temperature monitoring for the treatment of up to three HCC with diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion of the study will be the rate of complete ablation one month after one RFA procedure performed under MR temperature monitoring. The secondary criteria are, the 2-years local recurrence rate (after the first initial RF ablation procedure performed under MR temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant viable foci of tumor), the potential reduction of the number of RF procedures required to achieve complete necrosis and the complication rate of RF ablation procedure performed under MR temperature monitoring.
In exploratory attempt, the study will include comparative assessment of these criteria with a historic leg of patients previously treated by the same operator in the same center for similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.
Read the detailed description
The RF procedure and results assessment:
- In preparing MR room, the patient will be positioned on MR bed put on dedicated MR compatible trolley. The abdominal antenna will be installed.
- General anesthesia with tracheal intubation will be performed.
- Up to six RF electrodes (up to 6 depending on the size and the location of the tumor) will be inserted under ultrasound guidance.
- The patient will be translated without any direct manipulation in the magnet.
- With usual T1 and T2 weighted MR morphologic sequences the poisoning of electrode will be checked and if necessary adjusted
- Adjustment or MR temperature imaging (before RF energy deposition)
- Starting of RF procedure under MR temperature monitoring
- According to thermal dose maps data repositioning of electrodes and complementary energy deposition if necessary
- Hot withdrawal of electrodes
- Immediate (T0) post procedure MR assessment of the limits of ablation zone (T2 SPIRCHOL, Diffusion B600, In out phase, THRIVE dynamic after intravenous gadolinium injection).
After the procedure patients will be monitored at least 48 h.
MR assessment of treatment response will be performed one month after the procedure (same MR protocol performed at T0).
If the ablation is complete follow up will be ensured by MR every three months. If the ablation appeared incomplete or in case of recurrence additional RF ablation will be performed if the patient stills met the criteria of the treatment. The eventual additional RF ablation will be performed under ultrasound monitoring (the response to each additional RF ablation procedure will be assessed by MR one month after).
At the end of the study patients for whom complete radiological response of the tumor(s) initially treated (not local or distance recurrences) will be never achieved, will be considered in treatment failure.
Local recurrence is defined as the reappearance of viable tumor in contact of ablation zone of a tumor considered at least on one MR post therapeutic examination as completely ablated.
All the adverse effect and complication will be recorded and reported.
Quantitative analysis of 2D and 3D parameters of tumors and their related ablation zones as observed at the end of RF procedures on temperature maps using thermal dose concept (as previously extensively investigated) and with usual morphologic MR imaging (all used sequences) before, during and after the procedure (one month after) will be recorded and compared.
Antibioprophylaxy: will be prescribed in patients with an antecedent of endoscopic sphincterotomy (according to the CLIN protocol of Jean Verdier Hospital) and will be extended in patients : 1 older than 75 years , 2 patient with vesicular lithiasis 3) patients with nodule previously treated by embolization and those with a severe diabetes
- Conditions
- Hepatocellular Cancer
- Being tested
- Multipolar Radiofrequency ablation
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation, Multipolar mode, Recurrence, Cirrhosis, MR temperature monitoring, large tumor
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Recurrence, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multipolar Radiofrequency ablationProcedure or surgery
Also called Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| procedure | Experimental | Not described Receives: Procedure: Multipolar Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete ablation one month after one RFA procedure
Measured: One month after one RFA procedure
Secondary outcomes (5)
2-years local recurrence rate
Measured: 2 years
Number of procedure required to achieve complete ablation
Measured: One month after completion of treatment course
Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 RFA procedures performed monthly)
Measured: 1 month after completion of treatment
Complication rate per RF procedure under MR temperature monitoring
Measured: 2 years
Agreement of 2D and 3D measurements of ablations zones on IRMT° images and those measured on conventional magnitude MR images.
Measured: during and after the procedure (one month after)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study start20 Jun 2012
- Primary completion20 Jan 2016
- Study completion20 Dec 2016
Why it stopped: For technical reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEROR Olivier, MD-PHD, Principal investigator, CHU Jean VERDIER-Radiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486134
- Sponsor's protocol ID
- P100138/AOM 10266
- Other IDs
- 2011-A00007-34
- Acronym
- ARMTICH
- Status last verified
- May 2020
- First submitted
- 22 Nov 2011
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.
PubMed 19731239Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.
PubMed 18483229Seror O, Lepetit-Coiffe M, Quesson B, Trillaud H, Moonen CT. Quantitative magnetic resonance temperature mapping for real-time monitoring of radiofrequency ablation of the liver: an ex vivo study. Eur Radiol. 2006 Oct;16(10):2265-74. doi: 10.1007/s00330-006-0210-9. Epub 2006 Apr 11.
PubMed 16607496Seror O, Lepetit-Coiffe M, Le Bail B, de Senneville BD, Trillaud H, Moonen C, Quesson B. Real time monitoring of radiofrequency ablation based on MR thermometry and thermal dose in the pig liver in vivo. Eur Radiol. 2008 Feb;18(2):408-16. doi: 10.1007/s00330-007-0761-4. Epub 2007 Sep 26.
PubMed 17899103Lepetit-Coiffe M, Laumonier H, Seror O, Quesson B, Sesay MB, Moonen CT, Grenier N, Trillaud H. Real-time monitoring of radiofrequency ablation of liver tumors using thermal-dose calculation by MR temperature imaging: initial results in nine patients, including follow-up. Eur Radiol. 2010 Jan;20(1):193-201. doi: 10.1007/s00330-009-1532-1. Epub 2009 Aug 6.
PubMed 19657650
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Real Time MR Temperature Monitoring of Multipolar Radiofrequency Ablation of Large Hepatocellular Carcinomas (≥ 5 CM)-ARMTICH STUDY
- ClinicalTrials.gov ID
- NCT01486134
- Acronym / sponsor ID
- ARMTICH / P100138/AOM 10266
- Conditions
- Hepatocellular Cancer
- Keywords
- Hepatocellular carcinoma, Radiofrequency ablation, Multipolar mode, Recurrence, Cirrhosis, MR temperature monitoring, large tumor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For technical reasons
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 20 Jan 2016 (actual)
- Study completion
- 20 Dec 2016 (actual)
- First posted
- 6 Dec 2011 (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.
Object of the study:
To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors.
Experimental plan :
This pilot study consist to perform in a single center a single procedure of the multipolar RF ablation under MR temperature monitoring for the treatment of up to three HCC with diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion of the study will be the rate of complete ablation one month after one RFA procedure performed under MR temperature monitoring. The secondary criteria are, the 2-years local recurrence rate (after the first initial RF ablation procedure performed under MR temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant viable foci of tumor), the potential reduction of the number of RF procedures required to achieve complete necrosis and the complication rate of RF ablation procedure performed under MR temperature monitoring.
In exploratory attempt, the study will include comparative assessment of these criteria with a historic leg of patients previously treated by the same operator in the same center for similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.
Detailed description
The RF procedure and results assessment:
- In preparing MR room, the patient will be positioned on MR bed put on dedicated MR compatible trolley. The abdominal antenna will be installed.
- General anesthesia with tracheal intubation will be performed.
- Up to six RF electrodes (up to 6 depending on the size and the location of the tumor) will be inserted under ultrasound guidance.
- The patient will be translated without any direct manipulation in the magnet.
- With usual T1 and T2 weighted MR morphologic sequences the poisoning of electrode will be checked and if necessary adjusted
- Adjustment or MR temperature imaging (before RF energy deposition)
- Starting of RF procedure under MR temperature monitoring
- According to thermal dose maps data repositioning of electrodes and complementary energy deposition if necessary
- Hot withdrawal of electrodes
- Immediate (T0) post procedure MR assessment of the limits of ablation zone (T2 SPIRCHOL, Diffusion B600, In out phase, THRIVE dynamic after intravenous gadolinium injection).
After the procedure patients will be monitored at least 48 h.
MR assessment of treatment response will be performed one month after the procedure (same MR protocol performed at T0).
If the ablation is complete follow up will be ensured by MR every three months. If the ablation appeared incomplete or in case of recurrence additional RF ablation will be performed if the patient stills met the criteria of the treatment. The eventual additional RF ablation will be performed under ultrasound monitoring (the response to each additional RF ablation procedure will be assessed by MR one month after).
At the end of the study patients for whom complete radiological response of the tumor(s) initially treated (not local or distance recurrences) will be never achieved, will be considered in treatment failure.
Local recurrence is defined as the reappearance of viable tumor in contact of ablation zone of a tumor considered at least on one MR post therapeutic examination as completely ablated.
All the adverse effect and complication will be recorded and reported.
Quantitative analysis of 2D and 3D parameters of tumors and their related ablation zones as observed at the end of RF procedures on temperature maps using thermal dose concept (as previously extensively investigated) and with usual morphologic MR imaging (all used sequences) before, during and after the procedure (one month after) will be recorded and compared.
Antibioprophylaxy: will be prescribed in patients with an antecedent of endoscopic sphincterotomy (according to the CLIN protocol of Jean Verdier Hospital) and will be extended in patients : 1 older than 75 years , 2 patient with vesicular lithiasis 3) patients with nodule previously treated by embolization and those with a severe diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procedure | Experimental | Procedure: Multipolar Radiofrequency ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of 18 year old.
- Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
- Proof of underlying cirrhosis.
- Multidisciplinary decision of RF ablation treatment
- Informed consent of patient
Key exclusion criteria (17 listed)
- Patient with short term life training uncontrollable disease
- Pregnancy
- Follow up Impossible
- Contra indication for general anesthesia
- Contra indication for MR examination with gadolinium injection
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 |
|---|---|---|
| Multipolar Radiofrequency ablationAlso: Radiofrequency ablationPercutaneous multipolar radiofrequency ablation. | Procedure or surgery | procedure |
Primary outcome
Rate of complete ablation one month after one RFA procedure
Time frame: One month after one RFA procedure
5 secondary outcomes
2-years local recurrence rate
Time frame: 2 years
Number of procedure required to achieve complete ablation
Time frame: One month after completion of treatment course
Primary treatment effectiveness (assessed 1 month after completion of treatment course which can include up to 3 RFA procedures performed monthly)
Time frame: 1 month after completion of treatment
Complication rate per RF procedure under MR temperature monitoring
Time frame: 2 years
Agreement of 2D and 3D measurements of ablations zones on IRMT° images and those measured on conventional magnitude MR images.
Time frame: during and after the procedure (one month after)
Results and safety
The study was stopped early (reason given: For technical reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Background: PubMed 19731239N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.
- Background: PubMed 18483229Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.
- Background: PubMed 16607496Seror O, Lepetit-Coiffe M, Quesson B, Trillaud H, Moonen CT. Quantitative magnetic resonance temperature mapping for real-time monitoring of radiofrequency ablation of the liver: an ex vivo study. Eur Radiol. 2006 Oct;16(10):2265-74. doi: 10.1007/s00330-006-0210-9. Epub 2006 Apr 11.
- Background: PubMed 17899103Seror O, Lepetit-Coiffe M, Le Bail B, de Senneville BD, Trillaud H, Moonen C, Quesson B. Real time monitoring of radiofrequency ablation based on MR thermometry and thermal dose in the pig liver in vivo. Eur Radiol. 2008 Feb;18(2):408-16. doi: 10.1007/s00330-007-0761-4. Epub 2007 Sep 26.
- Background: PubMed 19657650Lepetit-Coiffe M, Laumonier H, Seror O, Quesson B, Sesay MB, Moonen CT, Grenier N, Trillaud H. Real-time monitoring of radiofrequency ablation of liver tumors using thermal-dose calculation by MR temperature imaging: initial results in nine patients, including follow-up. Eur Radiol. 2010 Jan;20(1):193-201. doi: 10.1007/s00330-009-1532-1. Epub 2009 Aug 6.
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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.
SEROR Olivier, MD-PHD principal investigator
CHU Jean VERDIER-Radiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multipolar Radiofrequency ablation in people with Hepatocellular Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 17 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: stopped early, as of the sponsor's last update on 13 May 2020. 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 France. 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 stopped early (reason given: For technical reasons). Results are not available in the source record.
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?
Rate of complete ablation one month after one RFA procedure (time frame: One month after one RFA procedure). 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 NCT01486134, which also lists 5 linked publications.
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 13 May 2020.