Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT02550613
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients.

Detailed Description

This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

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

Inclusion Criteria

1. Prior Informed Consent Form
2. At least one measurable tumor, according to RECIST version 1.1.
3. Age > 20 years.
4. ECOG performance status 0 or 1.
5. Life expectancy > 3 months.
6. Confirmed Diagnosis of HCC
7. Adequate renal function (Serum creatinine ≦ 1.5 x upper limit of normal).

Exclusion Criteria

1. Age <20 years old
2. Pregnancy
3. Contraindication for MRI: claustrophobia or MR non-compatible devices
4. Contraindication for MR contrast medium: severe adverse reaction or impaired renal function (Cre > 2.0)
5. History of other malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The recurrence rate at 3 months after treatment	3 months

Secondary Outcome Measures

Name	Time	Method
The overall survival after treatment	1 year

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan