Major RF Ablations of Hepatomas Under MR Thermometry Monitoring

NCT01486134 | Terminated DMC

• 2 other identifiers: P100138/AOM 102662011-A00007-34
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer

Keywords

Hepatocellular carcinoma; Radiofrequency ablation; Multipolar mode; Recurrence; Cirrhosis; MR temperature monitoring; large tumor

Outcome Measures

Primary Outcomes (1)

• Rate of complete ablation one month after one RFA procedure

  One month after one RFA procedure

Secondary Outcomes (5)

• 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)

Study Arms (1)

procedure

EXPERIMENTAL

Procedure: Multipolar Radiofrequency ablation

Interventions

Multipolar Radiofrequency ablation PROCEDURE

Percutaneous multipolar radiofrequency ablation.

Also known as: Radiofrequency ablation

procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Jean VERDIER

Bondy, 93140, France

Location

Related Publications (5)

• N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.

  PMID: 19731239 BACKGROUND

• Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.

  PMID: 18483229 BACKGROUND

• Seror O, Lepetit-Coiffe M, Quesson B, Trillaud H, Moonen CT. Quantitative magnetic resonance temperature mapping for real-time monitoring of radiofrequency ablation of the liver: an ex vivo study. Eur Radiol. 2006 Oct;16(10):2265-74. doi: 10.1007/s00330-006-0210-9. Epub 2006 Apr 11.

  PMID: 16607496 BACKGROUND

• Seror O, Lepetit-Coiffe M, Le Bail B, de Senneville BD, Trillaud H, Moonen C, Quesson B. Real time monitoring of radiofrequency ablation based on MR thermometry and thermal dose in the pig liver in vivo. Eur Radiol. 2008 Feb;18(2):408-16. doi: 10.1007/s00330-007-0761-4. Epub 2007 Sep 26.

  PMID: 17899103 BACKGROUND

• Lepetit-Coiffe M, Laumonier H, Seror O, Quesson B, Sesay MB, Moonen CT, Grenier N, Trillaud H. Real-time monitoring of radiofrequency ablation of liver tumors using thermal-dose calculation by MR temperature imaging: initial results in nine patients, including follow-up. Eur Radiol. 2010 Jan;20(1):193-201. doi: 10.1007/s00330-009-1532-1. Epub 2009 Aug 6.

  PMID: 19657650 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular; Recurrence; Fibrosis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• SEROR Olivier, MD-PHD

  CHU Jean VERDIER-Radiology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 6, 2011
• Study Start: June 20, 2012
• Primary Completion: January 20, 2016
• Study Completion: December 20, 2016
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

FR (1)