Intraprocedural assessment of Ablation Margins using COMPuted tomography co-registration in primary LivEr Tumor treatment with percutanEous ablation: IAMCOMPLETE primary

Recruiting

Conditions: Hepatocellular carcinoma/ primary liver cancer
10019654
10019815
10019818

Registration Number: NL-OMON55458

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

1. Age 18 yrs or above
2. HCC very early (0) or early stage (A) according to the BCLC staging system
Either de novo or recurrent HCC (prior locoregional therapy is allowed in the
study)
3. Candidate for percutaneous thermal ablation as discussed in a
multidisciplinary tumor board. Ablation as *bridge-to-transplant* is allowed in
the study

Exclusion Criteria

1. Estimated GFR <30 ml/min
2. Morbid obesitas or any pulmonary condition that is a contraindication to
prolonged apnea and high jet-ventilation
3. Child Pugh C liver status
4. Portal vein tumor invasion
5. Extrahepatic metastasis
6. Uncorrectable coagulopathy
7. Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule
8. Inability or unwillingness to give informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients in whom reliable co-registration with MIRADA RTx of<br /><br>pre- and post-ablation CT images is feasible</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Inter- and intraobserver variability of CT-CT co-registration to determine<br /><br>the minimum ablation margin after thermal ablation for liver tumors<br /><br>2. The time that is required for CT-CT co-registration<br /><br>3. Percentage of local recurrence per group as categorized according to<br /><br>ablation margin: <0mm, 0-5mm, >5mm</p><br>