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

NCT04123340 | Completed Phase 2

• 1 other identifier: NL69217.058.19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inter and intra-observer variability

  1 year

• The time that is required for CT-CT co-registration

  1 year

• Quantitatively assessed ablation margin

  1 year

Study Arms (1)

Additional intraprocedural CT-scan

EXPERIMENTAL

Additional intraprocedural CT-scan

Diagnostic Test: Additional intraprocedural pre-ablation CT-scan

Interventions

Additional intraprocedural pre-ablation CT-scan 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.

Additional intraprocedural CT-scan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Mirada Medical: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: post-procedural an assessment will be done of the ablation completeness using registration software. The actual ablation verification will be done qualitatively by the treating physician.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, single blind, single-arm, phase II stud

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: August 26, 2019
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: January 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)