Diffusion-Weighted Magnetic Resonance Imaging

Hepatocellular Carcinoma Clinical Trial

Official title:

Response Assessment for External Beam Radiation Therapy in Spinal Metastasis of Hepatocellular Carcinoma (HCC): Usefulness of Diffusion-Weighted Magnetic Resonance (MR) Imaging as A Functional Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02242786
• Other study ID #: 2013-07-174-003
• Status: Recruiting
• Phase: Phase 2
• First received: August 22, 2014
• Last updated: November 6, 2014
• Start date: August 2014

Study information

• Verified date: November 2014
• Source: Samsung Medical Center
• Contact: Jong Won Kwon, MD, PhD
• Phone: 82-2-3410-2548
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Neoplasm Metastasis
• Spine Metastasis

Intervention

Radiation:
• External beam radiation therapy

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral morphine equivalent doseresponse criteria	Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).	3 months after RT completion	No
Secondary	Modified Response Evaluation Criteria in Solid Tumor		3 months after RT completion	No
Secondary	Time to local tumor progression		From RT start to the date up to 24 weeks	No
Secondary	Overall survival		From RT start to the date up to 24 weeks	No
Secondary	Quality of Life	Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.	3 months after RT completion	No