3T MRI to Predict TACE Response of HCC

NCT02070822 | Unknown

• 1 other identifier: 201012077RB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma; Transarterial chemoembolization; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• tumor response

  change of tumor size from baseline to at 6 months

  change of tumor size from baseline to at 6 months

Secondary Outcomes (1)

• change of baseline MRI parameters

  change of MRI parameters from baseline to at 6 months

Study Arms (1)

TACE patients, for HCC

unresectable HCC patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital patients, admitted for TACE treatment of HCC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Uinversity Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bang-Bin Chen, MD

  National Taiwan Uinversity Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bang-Bin Chen, MD

CONTACT

bangbin@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: February 25, 2014
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

TW (1)