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3T MRI to Predict TACE Response of HCC

23. februar 2014 opdateret af: National Taiwan University Hospital

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

This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor responses. After day 28, all subjects will receive standard clinical care and be follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate with patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.

Studieoversigt

Status

Ukendt

Betingelser

Carcinom, hepatocellulært

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

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Taiwan
- - Taipei, Taiwan, 100
    - Rekruttering
    - National Taiwan Uinversity Hospital
    - Kontakt:
      
      Bang-Bin Chen, MD
      
      E-mail: bangbin@gmail.com
    - Ledende efterforsker:
      
      Bang-Bin Chen, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Hospital patients, admitted for TACE treatment of HCC

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
TACE patients, for HCC unresectable HCC patients

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
tumor response Tidsramme: 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

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	change of MRI parameters from baseline to at 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Efterforskere

Ledende efterforsker: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)