3T MRI to Predict TACE Response of HCC

Carcinoma, Hepatocellular Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02070822
• Other study ID #: 201012077RB
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2012
• Last updated: February 23, 2014
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: Bang-Bin Chen, MD
• Email: bangbin[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Locations

Country	Name	City	State
Taiwan	National Taiwan Uinversity Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response	change of tumor size from baseline to at 6 months	change of tumor size from baseline to at 6 months	No
Secondary	change of baseline MRI parameters	comparsion of MRI parameters from baseline to 6 months	change of MRI parameters from baseline to at 6 months	No