Trial Information

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

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.