- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan Uinversity Hospital
-
Contact:
- Bang-Bin Chen, MD
- Email: bangbin@gmail.com
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Principal Investigator:
- Bang-Bin Chen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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TACE patients, for HCC
unresectable HCC patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor response
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of baseline MRI parameters
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bang-Bin Chen, MD, National Taiwan Uinversity Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201012077RB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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