3T MRI to Predict TACE Response of HCC

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT02070822
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-02
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-23
• Last Update Submitted: 2014-02-23
• Study First Posted: 2014-02-25
• Last Update Posted: 2014-02-25
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
change of baseline MRI parameters	change of MRI parameters from baseline to at 6 months	comparsion of MRI parameters from baseline to 6 months

Trial Locations

Locations (1)

National Taiwan Uinversity Hospital; 🇨🇳 Taipei, Taiwan