3T MRI to Predict TACE Response of HCC
Combination of Dynamic Contrast-enhanced and Diffusion-weighted Imaging and Magnetic Resonance Spectroscopy in 3T MRI to Early Predict Treatment Efficacy in Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is a non-invasive quantitative technique for assessing micro-vascular structure by tracking the pharmacokinetics of injected low-molecular weight contrast agents as they pass through the tumor vasculature. This modality is being increasingly used in many oncological studies to characterize tumor angiogenesis and invasiveness, and monitor the treatment response.
Diffusion-weighted imaging (DWI) enables qualitative and quantitative assessment of tissue diffusivity (apparent diffusion coefficient, ADC) without the use of gadolinium chelates. DWI has been suggested to be useful in monitoring the response of HCC after TACE because of earlier assessment of tumor necrosis with increasing ADC values.
MR spectroscopy facilitates the study of cellular metabolism and in vivo detection of abnormalities. A few studies of in vivo MR spectroscopy reported an increase in choline levels within tumors such as HCC and a reduction in the lipid-to-choline ratio after conventional TACE was performed for HCC.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan Uinversity Hospital
-
Contacto:
- Bang-Bin Chen, MD
- Correo electrónico: bangbin@gmail.com
-
Investigador principal:
- Bang-Bin Chen, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Prior Informed Consent Form
- Patients who had undergone surgery for the treatment of HCC are allowed.
- At least one measurable tumor, according to RECIST version 1.1.
- Age more than 20 years.
- ECOG performance status 0 or 1.
- Life expectancy more than 3 months.
- Child-Pugh class A.
- Unresectable, multinodular tumors
- Confirmed Diagnosis of HCC
- At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- History of TACE
- Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis
- Any contraindications for hepatic embolization procedures:, including hepatofugal blood flow, large intrahepatic or porto-systemic shunt, impaired clotting test, renal failure requiring hemo-or peritoneal dialysis
- Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia.
- Other acute or chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and is inappropriate for this study by the judgment of the investigator
- Known history of HIV infection
- Concurrent primary extrahepatic cancer
- Pregnant or breast-feeding subjects
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
TACE patients, for HCC
unresectable HCC patients
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
tumor response
Periodo de tiempo: change of tumor size from baseline to at 6 months
|
change of tumor size from baseline to at 6 months
|
change of tumor size from baseline to at 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
change of baseline MRI parameters
Periodo de tiempo: change of MRI parameters from baseline to at 6 months
|
comparsion of MRI parameters from baseline to 6 months
|
change of MRI parameters from baseline to at 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201012077RB
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .