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Intraprocedural assessment of Ablation Margins using COMPuted tomography co-registration in primary LivEr Tumor treatment with percutanEous ablation: IAMCOMPLETE primary

Intraprocedural assessment of Ablation Margins using COMPuted tomography co-registration in primary LivEr Tumor treatment with percutanEous ablation: IAMCOMPLETE primary - IAMCOMPLETE primary

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55458
Enrollment
20
Registered
2019-09-23
Start date
2020-12-23
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma/ primary liver cancer

Interventions

Patients will undergo thermal ablation under general anesthesia as per usual. A CT with intravenous contrast will be performed immediately before and after the ablation, while the patient is under g

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 yrs or above 2. 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) 3. Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board. Ablation as *bridge-to-transplant* is allowed in the study

Exclusion criteria

Exclusion criteria: 1. Estimated GFR

Design outcomes

Primary

MeasureTime frame
The proportion of patients in whom reliable co-registration with MIRADA RTx of pre- and post-ablation CT images is feasible

Secondary

MeasureTime frame
1. Inter- and intraobserver variability of CT-CT co-registration to determine the minimum ablation margin after thermal ablation for liver tumors 2. The time that is required for CT-CT co-registration 3. Percentage of local recurrence per group as categorized according to ablation margin: 5mm

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)