- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan Uinversity Hospital
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Kontakt:
- Bang-Bin Chen, MD
- E-mail: bangbin@gmail.com
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Ledende efterforsker:
- Bang-Bin Chen, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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TACE patients, for HCC
unresectable HCC patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
tumor response
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
change of baseline MRI parameters
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201012077RB
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