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- Essai clinique NCT02070822
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Bang-Bin Chen, MD
- E-mail: bangbin@gmail.com
Lieux d'étude
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan Uinversity Hospital
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Contact:
- Bang-Bin Chen, MD
- E-mail: bangbin@gmail.com
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Chercheur principal:
- Bang-Bin Chen, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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TACE patients, for HCC
unresectable HCC patients
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
tumor response
Délai: change of tumor size from baseline to at 6 months
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change of tumor size from baseline to at 6 months
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change of tumor size from baseline to at 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change of baseline MRI parameters
Délai: change of MRI parameters from baseline to at 6 months
|
comparsion of MRI parameters from baseline to 6 months
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change of MRI parameters from baseline to at 6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 201012077RB
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