Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation (IAMCOMPLETE)

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 2

Conditions: HCC

Treatments: Diagnostic Test: Additional intraprocedural pre-ablation CT-scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04123340

NL69217.058.19

Details and patient eligibility

About

A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Additional intraprocedural CT-scan

Experimental group

Description:

Additional intraprocedural CT-scan

Treatment:

Diagnostic Test: Additional intraprocedural pre-ablation CT-scan