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Diffusion-Weighted Magnetic Resonance Imaging

NCT ID: NCT02242786

Last Updated: 2014-11-07

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

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Brief Summary

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Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic applications. Especially, it is expected the DW MRI could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (ADC) value change. It has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents.

The optimal assessment of early response of RT could provide one of the most important information to prescribe patient and cancer specific RT dose. It might be also important in palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.

This study is performed to evaluate the usefulness of DW MRI in early response evaluation after RT for HCC bone metastasis.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Spine Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBRT

Group Type EXPERIMENTAL

External beam radiation therapy

Intervention Type RADIATION

Interventions

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External beam radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Hepatocellular carcinoma
* Spine metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
* 20 or older age
* informed consent
* consent to birth control during 6 months after treatment

Exclusion Criteria

* less than 12 weeks of expected survival
* indication of emergency operation
* uncontrolled ascites or encephalopathy
* previous RT field lesion (within in 1 month)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Won Kwon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Won Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Won Kwon, MD, PhD

Role: CONTACT

82-2-3410-2548

Facility Contacts

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Jong Won Park, M.D., Ph.D.

Role: primary

82-2-3410-2548

Other Identifiers

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2013-07-174-003

Identifier Type: -

Identifier Source: org_study_id