Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Major RF Ablations of Hepatomas Under MR Thermometry Monitoring (ARMTICH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01486134
First received: November 22, 2011
Last updated: November 14, 2013
Last verified: November 2013

November 22, 2011
November 14, 2013
June 2012
December 2014   (final data collection date for primary outcome measure)
Rate of complete ablation one month after one RFA procedure [ Time Frame: One month after one RFA procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01486134 on ClinicalTrials.gov Archive Site
  • 2-years local recurrence rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Number of procedure required to achieve complete ablation [ Time Frame: One month after completion of treatment course ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Complication rate per RF procedure under MR temperature monitoring [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Major RF Ablations of Hepatomas Under MR Thermometry Monitoring
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.

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.

The RF procedure and results assessment:

  1. In preparing MR room, the patient will be positioned on MR bed put on dedicated MR compatible trolley. The abdominal antenna will be installed.
  2. General anaesthesia with tracheal intubation will be performed.
  3. Up to six RF electrodes (up to 6 depending on the size and the location of the tumor) will be inserted under ultrasound guidance.
  4. The patient will be translated without any direct manipulation in the magnet.
  5. With usual T1 and T2 weighted MR morphologic sequences the poisoning of electrode will be checked and if necessary adjusted
  6. Adjustment or MR temperature imaging (before RF energy deposition)
  7. Starting of RF procedure under MR temperature monitoring
  8. According to thermal dose maps data repositioning of electrodes and complementary energy deposition if necessary
  9. Hot withdrawal of electrodes
  10. 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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Cancer
Procedure: Multipolar Radiofrequency ablation
Percutaneous multipolar radiofrequency ablation.
Other Name: Radiofrequency ablation
Experimental: procedure
Intervention: Procedure: Multipolar Radiofrequency ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2017
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Tumor invisible on MR examination
  • Absence of safe percutaneous course to puncture the tumor
  • Child - Pugh B or C cirrhosis
  • Abundant ascites
  • PROTHROMBINE activity < 50 %
  • Platelet count < 40 .10 3/ml
Both
18 Years and older
No
Contact: Seror Olivier, MD-PHD +33 (0)1 48 02 58 68 olivier.seror@jvr.aphp.fr
France
 
NCT01486134
P100138/AOM 10266, 2011-A00007-34
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: SEROR Olivier, MD-PHD CHU Jean VERDIER-Radiology department
Assistance Publique - Hôpitaux de Paris
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP