Diffusion-Weighted Magnetic Resonance Imaging

NCT02242786 | Unknown Phase 2 DMC

• 1 other identifier: 2013-07-174-003
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Spine Metastasis

Outcome Measures

Primary Outcomes (1)

• oral morphine equivalent doseresponse criteria

  Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).

  3 months after RT completion

Secondary Outcomes (4)

• Modified Response Evaluation Criteria in Solid Tumor

  3 months after RT completion

• Time to local tumor progression

  From RT start to the date up to 24 weeks

• Overall survival

  From RT start to the date up to 24 weeks

• Quality of Life

  3 months after RT completion

Study Arms (1)

EBRT

EXPERIMENTAL

Radiation: External beam radiation therapy

Interventions

External beam radiation therapy RADIATION

EBRT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jong Won Park, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Won Kwon, MD, PhD

CONTACT

82-2-3410-2548

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: September 17, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

KR (1)