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

NCT ID: NCT02550613

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2018-04-30

Brief Summary

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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

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

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bang-Bin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Imaging, National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ting-Fang Shih, MD

Role: CONTACT

+886-2-23123456 ext. 65568

Facility Contacts

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Ting-Fang Shih, MD

Role: primary

+886-2-23123456 ext. 65568

Other Identifiers

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201401081MIND

Identifier Type: -

Identifier Source: org_study_id

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