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

NCT ID: NCT04123340

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2021-08-26

Brief Summary

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

Conditions

HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Additional intraprocedural CT-scan

Additional intraprocedural CT-scan

Group Type: EXPERIMENTAL

Additional intraprocedural pre-ablation CT-scan

Intervention Type: DIAGNOSTIC_TEST

In 20 patients, besides de regular post-RFA scan, a pre-RFA contrast enhanced dual phase CT-scan will be acquired to investigate the feasibility of quantitative ablation assessment.

Interventions

Additional intraprocedural pre-ablation CT-scan

In 20 patients, besides de regular post-RFA scan, a pre-RFA contrast enhanced dual phase CT-scan will be acquired to investigate the feasibility of quantitative ablation assessment.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirada Medical

UNKNOWN

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

MCBurgmans

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

NL69217.058.19

Identifier Type: -

Identifier Source: org_study_id