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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02550613
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 47
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Device: The imaging biomarkers determined by MR-PET

Detailed Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of Treatment Response With Integrated MRI/PET in Patients With Hepatocellular Carcinoma
• Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2018
• Anticipated Study Completion Date: Apr 1, 2018

Outcome Measures

Primary Outcome Measures

1. The recurrence rate at 3 months after treatment [3 months]

Secondary Outcome Measures

1. The overall survival after treatment [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Bang-Bin Chen, MD, Department of Medical Imaging, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT02550613
• Other Study ID Numbers: 201401081MIND
• First Posted: Sep 15, 2015
• Last Update Posted: May 16, 2017
• Last Verified: May 1, 2017

• Keywords provided by National Taiwan University Hospital: MR/PET, hepatocellular carcinoma, HCC
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 16, 2017