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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02550613
• Other study ID #: 201401081MIND
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2015
• Last updated: May 14, 2017
• Start date: May 2014
• Est. completion date: April 2018

Study information

• Verified date: May 2017
• Source: National Taiwan University Hospital
• Contact: Ting-Fang Shih, MD
• Phone: +886-2-23123456
• Email: ttfshih[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Device:
• The imaging biomarkers determined by MR-PET
The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients. This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).

Locations

Country	Name	City	State
Taiwan	National Taiwan University 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	The recurrence rate at 3 months after treatment		3 months
Secondary	The overall survival after treatment		1 year