NCT01486134: ARMTICH

Major RF Ablations of Hepatomas Under MR Thermometry Monitoring

Terminated NA Last updated 13 May 2020

What this trial tests

NA trial testing Multipolar Radiofrequency ablation in Hepatocellular Cancer in 15 participants. Terminated before completion.

Timeline

20 June 2012

Primary endpoint
20 January 2016

20 December 2016

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	20 June 2012
Primary completion	20 January 2016
Estimated completion	20 December 2016
Sites	1 location across France

Drugs / interventions tested

• Multipolar Radiofrequency ablation

Conditions studied

• Hepatocellular Cancer — all drugs for Hepatocellular Cancer →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.