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3T MRI to Predict TACE Response of HCC

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02070822
Collaborator
(none)
100
Enrollment
1
Location
40
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Aug 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    TACE patients, for HCC

    unresectable HCC patients

    Outcome Measures

    Primary Outcome Measures

    1. tumor response [change of tumor size from baseline to at 6 months]

      change of tumor size from baseline to at 6 months

    Secondary Outcome Measures

    1. change of baseline MRI parameters [change of MRI parameters from baseline to at 6 months]

      comparsion of MRI parameters from baseline to 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Prior Informed Consent Form

    2. Patients who had undergone surgery for the treatment of HCC are allowed.

    3. At least one measurable tumor, according to RECIST version 1.1.

    4. Age more than 20 years.

    5. ECOG performance status 0 or 1.

    6. Life expectancy more than 3 months.

    7. Child-Pugh class A.

    8. Unresectable, multinodular tumors

    9. Confirmed Diagnosis of HCC

    10. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI

    11. Adequate bone marrow, liver and renal function

    Exclusion Criteria:

    1. History of TACE

    2. Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis

    3. 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

    4. Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia.

    5. 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

    6. Known history of HIV infection

    7. Concurrent primary extrahepatic cancer

    8. Pregnant or breast-feeding subjects

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan Uinversity Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT02070822
    Other Study ID Numbers:
    • 201012077RB
    First Posted:
    Feb 25, 2014
    Last Update Posted:
    Feb 25, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by National Taiwan University Hospital
    Hepatocellular carcinoma
    Transarterial chemoembolization
    Magnetic resonance imaging
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Feb 25, 2014