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

HCC Clinical Trial

— IAMCOMPLETE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04123340
• Other study ID #: NL69217.058.19
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2019
• Est. completion date: August 26, 2021

Study information

• Verified date: January 2023
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 26, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HCC
• Liver Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Mirada Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the use of co-registration software (>80%)	The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible	1 year
Secondary	Inter and intra-observer variability	Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors	1 year
Secondary	The time that is required for CT-CT co-registration	The time that is required for CT-CT co-registration	1 year
Secondary	Quantitatively assessed ablation margin	Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm	1 year