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

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ClinicalTrials.gov Identifier: NCT04123340
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Mirada Medical
Information provided by (Responsible Party):
MCBurgmans, Leiden University Medical Center

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

Condition or disease Intervention/treatment Phase
HCC Diagnostic Test: Additional intraprocedural pre-ablation CT-scan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, single blind, single-arm, phase II stud
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Additional intraprocedural CT-scan
Additional intraprocedural CT-scan
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.




Primary Outcome Measures :
  1. Feasibility of the use of co-registration software (>90%) [ Time Frame: 1 year ]
    The proportion of patients in whom reliable co-registration with MIRADA RTx of pre- and post-ablation CT images is feasible


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123340


Contacts
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Contact: Mark C. Burgmans, MD, PhD +31-71 5262410 m.c.burgmans@lumc.nl
Contact: Pim Hendriks, MSc. +31-71 5262410 p.hendriks@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333ZA
Contact: Mark Burgmans, MD, PhD    +31-71 5262410    m.c.burgmans@lumc.nl   
Contact: Pim Hendriks, MSc.    +31-71 5298161    p.hendriks@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
Mirada Medical

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Responsible Party: MCBurgmans, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04123340     History of Changes
Other Study ID Numbers: NL69217.058.19
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual patiend data is shared with researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases