Liver CancerEmeritusNCT04269499
Real-time Imaging of Holmium Radioembolization: a Feasibility Study
A study testing QuiremSpheres® in people with Liver Cancer and Liver Metastases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastases
- What is being tested?
- QuiremSpheres®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2019to 10 May 2021
- 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
- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver (primary tumours: colorectal cancer, melanoma, breast cancer or neuro-endocrine tumour) with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
- Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
- Life expectancy of 12 weeks or longer.
- World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
- One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- Negative pregnancy test for women of childbearing potential.
Who cannot join
- Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
- Radiation therapy within the last 4 weeks before the start of study therapy.
- The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
- Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
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- Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- Leukocytes < 4.0 109/l and/or platelet count < 60 109/l.
- Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Pregnancy or breast feeding (women of child-bearing potential).
- Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
- Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- Patients ineligible to undergo MR imaging.
- Patients who are claustrophobic.
- Patient who had prior liver resection and/or coil placement inside the liver, expected to cause imaging artefacts on MRI that will limit MR quantification.
- Patients who are declared incompetent.
- Previous enrolment in the present study or previous treatment with radioembolisation.
- Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
- Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
- Untreated active hepatitis.
- Transjugular intrahepatic portosystemic shunt (TIPS).
- Body weight over 150 kg (because of maximum table load).
- Severe allergy for intravenous contrast agents used
- Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
- Dotarem or Primovist, depending on the agent used at the time of treatment
- Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
- Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Centre
Nijmegen, Gelderland, 6525GA
About this study
Official title: Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary or Secondary Liver Cancer; a Feasibility Study
This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.
- Conditions
- Liver Cancer, Liver Metastases
- Being tested
- QuiremSpheres®
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuiremSpheres®Device
Radioembolization with QuiremSpheres® under MR imaging
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Other | All patients receive holmium radioembolization as per usual Receives: Device: QuiremSpheres® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of MR imaged administration of holmium microspheres
Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.
Measured: 1 month after inclusion
Secondary outcomes (4)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Patients are followed up to 3 months after treatment, during which all adverse events are recorded.
Measured: Up to 3 months after treatment
Tumor/non-tumor ratio on MR based dosimetry
MR based dosimetry is performed immediately after treatment, resulting in dose maps. The dose that the tumor received is divided over the dose that the rest of the liver received.
Measured: 1 month after inclusion
Comparison of dosimetry in Gray between MR based and SPECT based dose maps
Voxel-based dosimetry will be performed, leading to dose-volume histograms with a dose value per voxel in Gray. Statistical testing will be done for differences between these data sets, i.e. the two different imaging modalities (MR based and SPECT based). It is expected that dose-volume histograms will be similar between the two modalities.
Measured: 1 month after inclusion
Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria)
Measured: 3 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 posted13 Feb 2020
- Study start11 Nov 2019
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Radboud University 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, interventional, feasibility
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Quirem Medical B.V.
- Responsible party
- Sponsor
- Investigators
- Frank Nijsen, PhD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269499
- Sponsor's protocol ID
- 18100 Emeritus
- Acronym
- Emeritus
- Status last verified
- Jun 2021
- First submitted
- 7 Feb 2020
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van den Brekel A, Snoeijink TJ, de Meijer VE, Boswinkel M, de Jong KP, Roosen J, Arranja AG, Futterer JJ, Ruiter SJS, Nijsen JFW. Spatial distribution of fractionally administered holmium microspheres in non-tumorous human liver tissue: how livers survive transarterial radioembolisation. EJNMMI Res. 2025 Apr 28;15(1):49. doi: 10.1186/s13550-025-01240-8.
PubMed 40289050Roosen J, Westlund Gotby LEL, Arntz MJ, Futterer JJ, Janssen MJR, Konijnenberg MW, van Wijk MWM, Overduin CG, Nijsen JFW. Intraprocedural MRI-based dosimetry during transarterial radioembolization of liver tumours with holmium-166 microspheres (EMERITUS-1): a phase I trial towards adaptive, image-controlled treatment delivery. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4705-4715. doi: 10.1007/s00259-022-05902-w. Epub 2022 Jul 13.
PubMed 35829749
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. 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 or Secondary Liver Cancer; a Feasibility Study
- ClinicalTrials.gov ID
- NCT04269499
- Acronym / sponsor ID
- Emeritus / 18100 Emeritus
- Conditions
- Liver Cancer, Liver Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Quirem Medical B.V.
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 13 Feb 2020 (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 is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, interventional, feasibility
| Arm | Type | Receives |
|---|---|---|
| Study patients | Other | Device: QuiremSpheres®All patients receive holmium radioembolization as per usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver (primary tumours: colorectal cancer, melanoma, breast cancer or neuro-endocrine tumour) with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
- Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
- Life expectancy of 12 weeks or longer.
Key exclusion criteria (28 listed)
- Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
- Radiation therapy within the last 4 weeks before the start of study therapy.
- The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
- Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
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 |
|---|---|---|
| QuiremSpheres®Radioembolization with QuiremSpheres® under MR imaging | Device | Study patients |
Primary outcome
Feasibility of MR imaged administration of holmium microspheres
Time frame: 1 month after inclusion
Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 3 months after treatment
Tumor/non-tumor ratio on MR based dosimetry
Time frame: 1 month after inclusion
Comparison of dosimetry in Gray between MR based and SPECT based dose maps
Time frame: 1 month after inclusion
Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria)
Time frame: 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Derived from this study: PubMed 40289050van den Brekel A, Snoeijink TJ, de Meijer VE, Boswinkel M, de Jong KP, Roosen J, Arranja AG, Futterer JJ, Ruiter SJS, Nijsen JFW. Spatial distribution of fractionally administered holmium microspheres in non-tumorous human liver tissue: how livers survive transarterial radioembolisation. EJNMMI Res. 2025 Apr 28;15(1):49. doi: 10.1186/s13550-025-01240-8.
- Derived from this study: PubMed 35829749Roosen J, Westlund Gotby LEL, Arntz MJ, Futterer JJ, Janssen MJR, Konijnenberg MW, van Wijk MWM, Overduin CG, Nijsen JFW. Intraprocedural MRI-based dosimetry during transarterial radioembolization of liver tumours with holmium-166 microspheres (EMERITUS-1): a phase I trial towards adaptive, image-controlled treatment delivery. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4705-4715. doi: 10.1007/s00259-022-05902-w. Epub 2022 Jul 13.
- Individual participant dataSharing planned: Undecided
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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
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QuiremSpheres® in people with Liver Cancer and Liver Metastases, 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 8 inclusion and 28 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: finished, as of the sponsor's last update on 29 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of MR imaged administration of holmium microspheres (time frame: 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269499, which also lists 2 linked publications.
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 29 Jun 2021.