Status:
COMPLETED
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Mirada Medical
Conditions:
HCC
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
Eligibility Criteria
Inclusion
- Age 18 yrs or above
- 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)
- Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. Ablation as 'bridge-to-transplant' is allowed in the study
Exclusion
- Estimated GFR \<30 ml/min
- Morbid obesitas or any pulmonary condition that is a contraindication to prolonged apnea and high jet-ventilation
- Child Pugh C
- Portal vein tumor invasion
- Extrahepatic metastasis
- Uncorrectable coagulopathy
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Inability or unwillingness to give informed consent
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04123340
Start Date
August 26 2019
End Date
August 26 2021
Last Update
January 6 2023
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA