Major RF Ablations of Hepatomas Under MR Thermometry Monitoring
Conditions
Hepatocellular Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
Hepatocellular carcinoma, Radiofrequency ablation, Multipolar mode, Recurrence, Cirrhosis, MR temperature monitoring, large tumor
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Multipolar Radiofrequency ablation
Type: Procedure
Overall Status
Recruiting
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.
Detailed Description
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 anesthesia 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.

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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
CHU Jean VERDIER
Bondy, France
Status: Recruiting
Contact: Seror Olivier, MD-PHD - +33 (0)1 48 02 58 68 - olivier.seror@jvr.aphp.fr
Start Date
June 2012
Completion Date
January 2018
Sponsors
Assistance Publique - Hôpitaux de Paris
Source
Assistance Publique - Hôpitaux de Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page