Back to resultsIntraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation (IAMCOMPLETE)
Primary Purpose
HCC
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Additional intraprocedural pre-ablation CT-scan
Sponsored by
About this trial
This is an interventional treatment trial for HCC
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
Sites / Locations
- Leiden University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Additional intraprocedural CT-scan
Arm Description
Additional intraprocedural CT-scan
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
The time that is required for CT-CT co-registration
The time that is required for CT-CT co-registration
Quantitatively assessed ablation margin
Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm
Full Information
NCT ID
NCT04123340
First Posted
October 9, 2019
Last Updated
January 4, 2023
Sponsor
Leiden University Medical Center
Collaborators
Mirada Medical
1. Study Identification
Unique Protocol Identification Number
NCT04123340
Brief Title
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
Acronym
IAMCOMPLETE
Official Title
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
Mirada Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Additional intraprocedural CT-scan
Arm Type
Experimental
Arm Description
Additional intraprocedural CT-scan
Intervention Type
Diagnostic Test
Intervention Name(s)
Additional intraprocedural pre-ablation CT-scan
Intervention Description
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 Measure Information:
Title
Feasibility of the use of co-registration software (>80%)
Description
The proportion of patients in whom reliable co-registration of pre- and post-ablation CT images is feasible
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Inter and intra-observer variability
Description
Inter- and intraobserver variability of CT-CT co-registration of determining the minimum ablation margin after thermal ablation for liver tumors
Time Frame
1 year
Title
The time that is required for CT-CT co-registration
Description
The time that is required for CT-CT co-registration
Time Frame
1 year
Title
Quantitatively assessed ablation margin
Description
Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333ZA
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual patiend data is shared with researchers.
Learn more about this trial
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
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