Clinical trial NCT02070822: 3T MRI to Predict TACE Response of HCC
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma
Transarterial chemoembolization
Magnetic resonance imaging
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients, admitted for TACE treatment of HCC

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.

Eligibility criteria: 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

Primary outcomes:
measure: tumor response
timeFrame: change of tumor size from baseline to at 6 months
Secondary outcomes:
measure: change of baseline MRI parameters
timeFrame: change of MRI parameters from baseline to at 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Uinversity Hospital
Study officials:
affiliation: National Taiwan Uinversity Hospital
name: Bang-Bin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: