HCCPhase 2IAMCOMPLETENCT04123340
Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
A Phase 2 study testing Additional intraprocedural pre-ablation CT-scan in people with HCC, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HCC
- What is being tested?
- Additional intraprocedural pre-ablation CT-scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Aug 2019to 26 Aug 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
- Conditions
- HCC
- Being tested
- Additional intraprocedural pre-ablation CT-scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional intraprocedural pre-ablation CT-scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Additional intraprocedural CT-scan | Experimental | Additional intraprocedural CT-scan Receives: Diagnostic Test: Additional intraprocedural pre-ablation CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
The time that is required for CT-CT co-registration
The time that is required for CT-CT co-registration
Measured: 1 year
Quantitatively assessed ablation margin
Percentage of local recurrence per group as categorized according to ablation margin: <0mm, 0-5mm, >5mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start26 Aug 2019
- Primary completion26 Aug 2021
- Study completion26 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single blind, single-arm, phase II stud
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mirada Medical
- Responsible party
- Principal investigator, MCBurgmans, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123340
- Sponsor's protocol ID
- NL69217.058.19
- Acronym
- IAMCOMPLETE
- Status last verified
- Jan 2023
- First submitted
- 9 Oct 2019
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patiend data is shared with researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraprocedural Assessment of Ablation Margins Using Computed Tomography Co-registration in Primary Liver Tumor Treatment With Percutaneous Ablation
- ClinicalTrials.gov ID
- NCT04123340
- Acronym / sponsor ID
- IAMCOMPLETE / NL69217.058.19
- Conditions
- HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Mirada Medical
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pre- and postablation scan will be made intraprocedurally to investigate the feasibility of intraprocedural ablation verification assessment using coregistration software
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single blind, single-arm, phase II stud
| Arm | Type | Receives |
|---|---|---|
| Additional intraprocedural CT-scan | Experimental | Diagnostic Test: Additional intraprocedural pre-ablation CT-scanAdditional intraprocedural CT-scan |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional intraprocedural pre-ablation CT-scanIn 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. | Diagnostic test | Additional intraprocedural CT-scan |
Primary outcome
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
3 secondary outcomes
Inter and intra-observer variability
Time frame: 1 year
The time that is required for CT-CT co-registration
Time frame: 1 year
Quantitatively assessed ablation margin
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No. No individual patiend data is shared with researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Additional intraprocedural pre-ablation CT-scan in people with HCC, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the use of co-registration software (>80%) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.