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OpenTrials
Completed

NCT Number: NCT04123340

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

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

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Key information

Conditions

HCC

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the use of co-registration software (>80%)

    Time frame: 1 year

    The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible

Secondary outcomes

  1. Inter and intra-observer variability

    Time frame: 1 year

    Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors

  2. The time that is required for CT-CT co-registration

    Time frame: 1 year

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

  3. Quantitatively assessed ablation margin

    Time frame: 1 year

    Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Mirada Medical

Registry information

Acronym: IAMCOMPLETE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2019
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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