Primary Liver CancerEMERITUS-2NCT05609448
MRI-guided Holmium-166 Radioembolization
A study testing MRI-guided radioembolization in people with Primary Liver Cancer and Non-Resectable Hepatocellular Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Cancer, Non-Resectable Hepatocellular Carcinoma
- What is being tested?
- MRI-guided radioembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2023to Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hepatocellular carcinoma BCLC stage B or C
- At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT
- Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO)
- Patient has a life expectancy of 12 weeks or longer
- Patient has a WHO performance score of 0-2
Who cannot join
- Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)
- Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
- Serum bilirubin > 2.0 x the upper limit of normal
- ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
- Leukocytes <4.0 * 109/L or platelet count <60 * 109/L
- Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.
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- Pregnancy or breast feeding
- Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum
- Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)
- Portal vein thrombosis of the main branch (more distal branches are allowed)
- Untreated, active hepatitis
- Body weight > 150 kg (because of maximum table load)
- Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
- Lung shunt > 30 Gy, as calculated using scout dose 166Ho SPECT/CT.
- Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
- Unstable final catheter position due to hepatic artery anatomy, which might lead to dislocation of the catheter during transfer to the MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
- Being tested
- MRI-guided radioembolization
- Keywords
- hepatocellular carcinoma, radioembolization, TARE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI-guided radioembolizationProcedure or surgery
Catheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration.
| Study group | Role | What they receive |
|---|---|---|
| MRI-guided radioembolization | Experimental | Study patients will receive radioembolization with holmium microspheres in an MRI guided setting. Receives: Procedure: MRI-guided radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity profile of dose administration cohorts
Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
Measured: 12 months after treatment
Safety of MRI-guided radioembolization procedure
Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.
Measured: 12 months after treatment
Time constraints of performing intraprocedural MRI-based dosimetry
Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.
Measured: during treatment procedure
Feasibility of performing intraprocedural treatment planning
The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.
Measured: during treatment procedure
Secondary outcomes (1)
Dosimetry optimization
Perform optimization of holmium dosimetry using SPECT and MRI
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start23 May 2023
- Primary completionJan 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Frank Nijsen, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609448
- Sponsor's protocol ID
- EMERITUS-2
- Acronym
- EMERITUS-2
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available to other researchers upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary Liver Cancer; a Single Center, Interventional, Non-randomized, Feasibility Study
- ClinicalTrials.gov ID
- NCT05609448
- Acronym / sponsor ID
- EMERITUS-2 / EMERITUS-2
- Keywords
- hepatocellular carcinoma, radioembolization, TARE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 23 May 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Nov 2022 (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.
To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-guided radioembolization | Experimental | Procedure: MRI-guided radioembolizationStudy patients will receive radioembolization with holmium microspheres in an MRI guided setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of hepatocellular carcinoma BCLC stage B or C
- At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT
- Patient is eligible for TARE as determined by the tumour board (in Dutch: MDO)
- Patient has a life expectancy of 12 weeks or longer
- Patient has a WHO performance score of 0-2
Key exclusion criteria (16 listed)
- Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)
- Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
- Serum bilirubin > 2.0 x the upper limit of normal
- ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
- Leukocytes <4.0 * 109/L or platelet count <60 * 109/L
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 |
|---|---|---|
| MRI-guided radioembolizationCatheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration. | Procedure or surgery | MRI-guided radioembolization |
Primary outcome
Toxicity profile of dose administration cohorts
Time frame: 12 months after treatment
Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.
Safety of MRI-guided radioembolization procedure
Time frame: 12 months after treatment
Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.
Time constraints of performing intraprocedural MRI-based dosimetry
Time frame: during treatment procedure
Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.
Feasibility of performing intraprocedural treatment planning
Time frame: during treatment procedure
The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.
1 secondary outcome
Dosimetry optimization
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data is available to other researchers upon reasonable request
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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.
Frank Nijsen, PhD principal investigator
Radboud University Medical Center
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-guided radioembolization in people with Primary Liver Cancer and Non-Resectable Hepatocellular Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 16 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 18 Nov 2023. 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 Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity profile of dose administration cohorts (time frame: 12 months after treatment). The study lists 4 primary outcomes in all. 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 18 Nov 2023.