Hepatocellular CarcinomaNCT03731910
Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
A study testing MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate the value of early change at MRI in HCC treated with TARE, for evaluation/prediction of treatment response and prognosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2018to 30 Jun 2023
- Phase
- Interventional
- 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
- Intermediate or locally advanced HCC according to Hong Kong Liver Cancer guideline
- Scheduled for transarterial radioembolization (TARE)
- sign informed consent
Who cannot join
- Any absolute or relative contra-indication of contrast-enhanced MRI
- History of other local treatment before TARE in 3 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Hyun Hee Lee, RN, 82-2-2072-4177, redlion55@naver.com
Jeong Hee Yoon, MD, 82-2-2072-2584, cinamon1@snu.ac.kr
About this study
Official title: Short Term Magnetic Resonance Imaging (MRI) for Treatment Response Evaluation and Prognosis Prediction in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Radioembolization (TARE)
This study aims to investigate the value of early change at MRI in HCC treated with TARE, for evaluation/prediction of treatment response and prognosis.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MRI
- Keywords
- MRI
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called magnetic resonance imaging
liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.
| Study group | Role | What they receive |
|---|---|---|
| HCC group | Experimental | Participants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response mRECIST
treatment response using mRECIST
Measured: 1 month after last MRI
Secondary outcomes (5)
Tumor diffusion
measured with diffusion-weighted image sequence
Measured: 1 months after last MRI
Tumor perfusion
measured with dynamic contrast-enhanced imaging
Measured: 1 months after last MRI
Treatment response LI-RADS
treatment response using LI-RADSv 2018 treatment response category
Measured: 1 months after last MRI
Treatment response volumetric
treatment response using volumetric response criteria
Measured: 1 months after last MRI
Time to Progression
Time until to definite progression on follow-up images
Measured: 24 months after TARE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start11 Dec 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (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 Seoul National University HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongkook Lifesicence
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731910
- Sponsor's protocol ID
- SNUH-1807-149-957
- Status last verified
- Dec 2021
- First submitted
- 4 Nov 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Magnetic Resonance Imaging (MRI) for Treatment Response Evaluation and Prognosis Prediction in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Radioembolization (TARE)
- ClinicalTrials.gov ID
- NCT03731910
- Acronym / sponsor ID
- SNUH-1807-149-957
- Conditions
- Hepatocellular Carcinoma
- Keywords
- MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dongkook Lifesicence
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Nov 2018 (actual)
- 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.
This study aims to investigate the value of early change at MRI in HCC treated with TARE, for evaluation/prediction of treatment response and prognosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC group | Experimental | Diagnostic Test: MRIParticipants who are scheduled for TARE for HCC treatment. They undergo MRI three times- before, 1- and 2-week after TARE. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intermediate or locally advanced HCC according to Hong Kong Liver Cancer guideline
- Scheduled for transarterial radioembolization (TARE)
- sign informed consent
Key exclusion criteria (2 listed)
- Any absolute or relative contra-indication of contrast-enhanced MRI
- History of other local treatment before TARE in 3 weeks
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 |
|---|---|---|
| MRIAlso: magnetic resonance imagingliver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image. | Diagnostic test | HCC group |
Primary outcome
Treatment response mRECIST
Time frame: 1 month after last MRI
treatment response using mRECIST
5 secondary outcomes
Tumor diffusion
Time frame: 1 months after last MRI
Tumor perfusion
Time frame: 1 months after last MRI
Treatment response LI-RADS
Time frame: 1 months after last MRI
Treatment response volumetric
Time frame: 1 months after last MRI
Time to Progression
Time frame: 24 months after TARE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Jeong Min Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital 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 3 inclusion and 2 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 17 Dec 2021. 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.
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 Hyun Hee Lee, RN (82-2-2072-4177, redlion55@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response mRECIST (time frame: 1 month after last MRI). 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 17 Dec 2021.