ARMTICH: Major RF Ablations of Hepatomas Under MR Thermometry Monitoring

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT01486134

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer	Procedure: Multipolar Radiofrequency ablation	N/A

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

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Real Time MR Temperature Monitoring of Multipolar Radiofrequency Ablation of Large Hepatocellular Carcinomas (≥ 5 CM)-ARMTICH STUDY

Actual Study Start Date :

Jun 20, 2012

Actual Primary Completion Date :

Jan 20, 2016

Actual Study Completion Date :

Dec 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: procedure	Procedure: Multipolar Radiofrequency ablation Percutaneous multipolar radiofrequency ablation. Other Names: Radiofrequency ablation

Arm

Intervention/Treatment

Experimental: procedure

Procedure: Multipolar Radiofrequency ablation

Percutaneous multipolar radiofrequency ablation.

Other Names:

Radiofrequency ablation

Outcome Measures

Primary Outcome Measures

Rate of complete ablation one month after one RFA procedure [One month after one RFA procedure]

Secondary Outcome Measures

2-years local recurrence rate [2 years]
Number of procedure required to achieve complete ablation [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) [1 month after completion of treatment]
Complication rate per RF procedure under MR temperature monitoring [2 years]
Agreement of 2D and 3D measurements of ablations zones on IRMT° images and those measured on conventional magnitude MR images. [during and after the procedure (one month after)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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