Hepatocellular CarcinomaPhase 2NCT02242786
Diffusion-Weighted Magnetic Resonance Imaging
A Phase 2 study testing External beam radiation therapy in people with Hepatocellular Carcinoma and Spine Metastasis, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Spine Metastasis
- What is being tested?
- External beam radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 12 weeks of expected survival
- indication of emergency operation
- uncontrolled ascites or encephalopathy
- previous RT field lesion (within in 1 month)
Trial locations and contacts
1 site in 1 country.
Jong Won Kwon, MD, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jong Won Park, M.D., Ph.D., 82-2-3410-2548
Hee Chul Park, M.D., Ph.D.
About this study
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
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
- Being tested
- External beam radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| EBRT | Experimental | Not described Receives: Radiation: External beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral morphine equivalent doseresponse criteria
Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
Measured: 3 months after RT completion
Secondary outcomes (4)
Modified Response Evaluation Criteria in Solid Tumor
Measured: 3 months after RT completion
Time to local tumor progression
Measured: From RT start to the date up to 24 weeks
Overall survival
Measured: From RT start to the date up to 24 weeks
Quality of Life
Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.
Measured: 3 months after RT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Won Kwon, Samsung Medical Center
- Investigators
- Jong Won Park, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242786
- Sponsor's protocol ID
- 2013-07-174-003
- Status last verified
- Nov 2014
- First submitted
- 22 Aug 2014
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02242786
- Acronym / sponsor ID
- 2013-07-174-003
- Conditions
- Hepatocellular Carcinoma, Spine Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBRT | Experimental | Radiation: External beam radiation therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hepatocellular carcinoma
- Spine metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- 20 or older age
- informed consent
Key exclusion criteria (4 listed)
- less than 12 weeks of expected survival
- indication of emergency operation
- uncontrolled ascites or encephalopathy
- previous RT field lesion (within in 1 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiation therapy | Radiation | EBRT |
Primary outcome
oral morphine equivalent doseresponse criteria
Time frame: 3 months after RT completion
Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
4 secondary outcomes
Modified Response Evaluation Criteria in Solid Tumor
Time frame: 3 months after RT completion
Time to local tumor progression
Time frame: From RT start to the date up to 24 weeks
Overall survival
Time frame: From RT start to the date up to 24 weeks
Quality of Life
Time frame: 3 months after RT completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Won Kwon, MD, PhD contact
Jong Won Park, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External beam radiation therapy in people with Hepatocellular Carcinoma and Spine Metastasis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Won Kwon, MD, PhD (82-2-3410-2548), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral morphine equivalent doseresponse criteria (time frame: 3 months after RT completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2014; AzTrials last refreshed its copy on 27 Oct 2026.