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

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

Patrocinadores

Patrocinador principal: Leiden University Medical Center

Colaborador: Mirada Medical

Fuente Leiden University Medical Center
Resumen breve

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

Estado general Recruiting
Fecha de inicio September 27, 2019
Fecha de Terminación October 1, 2021
Fecha de finalización primaria October 1, 2020
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Feasibility of the use of co-registration software (>90%) 1 year
Resultado secundario
Medida Periodo de tiempo
Inter and intra-observer variability 1 year
The time that is required for CT-CT co-registration 1 year
Quantitatively assessed ablation margin 1 year
Inscripción 20
Condición
Intervención

Tipo de intervención: Diagnostic Test

Nombre de intervención: Additional intraprocedural pre-ablation CT-scan

Descripción: 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.

Etiqueta de grupo de brazo: Additional intraprocedural CT-scan

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 99 Years

Voluntarios Saludables: No

Contacto general

Apellido: Mark C. Burgmans, MD, PhD

Teléfono: +31-71 5262410

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Leiden University Medical Center Mark Burgmans, MD, PhD +31-71 5262410 [email protected]
Ubicacion Paises

Netherlands

Fecha de verificación

October 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Leiden University Medical Center

Nombre completo del investigador: MCBurgmans

Título del investigador: Principal Investigator

Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Additional intraprocedural CT-scan

Tipo: Experimental

Descripción: Additional intraprocedural CT-scan

Acrónimo IAMCOMPLETE
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: prospective, single blind, single-arm, phase II stud

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Descripción de enmascaramiento: 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.

Fuente: ClinicalTrials.gov