Carcinoma, HepatocellularRHEPaiRNCT06302400
Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma
A study testing 166Holmium microspheres (QuiremSpheres®) in people with Carcinoma, Hepatocellular, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- 166Holmium microspheres (QuiremSpheres®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2024to 4 Mar 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
- Provided written informed consent.
- Female or male aged 18 years and over.
- Diagnosis of HCC established according to AASLD criteria: nodule >1 cm in a patient at risk for HCC, with combination of arterial hypervascularity and venous or delayed phase wash-out on multiphase CT-scan or MRI-scan. LR-5 and LR- 4 based on Liver Imaging Reporting and Data System can be included.
- No curative treatment options (resection, transplant, or in case of solitary tumour, RFA).
- Life expectancy of at least 6 months.
- ECOG Performance status 0-1.
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- Liver-dominant disease (maximum 5 lung nodules all ≤1.0 cm, solitary clinically stable adrenal metastasis, and mesenteric or portal lymph nodes all ≤2.0 cm are accepted).
- Child-Pugh class A5-6 or B7.
- At least one measurable liver lesion according to the modified RECIST criteria.
- Negative pregnancy test for women of childbearing potential. Female patients of childbearing potential should use a highly effective acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) or should be more than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form), to prevent pregnancy.
Who cannot join
- Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening).
- Hepatic radiation therapy within the last 4 weeks before the start of study therapy.
- Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with systemic treatment are allowed.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Serum bilirubin > 34 umol/L in the absence of a reversible cause
- Glomerular filtration rate <35 ml/min.
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- Non-correctable INR >1.5 in case of femoral approach (as opposed to radial).
- Platelet count <50 109/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 breastfeeding.
- Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression.
- Patients who are declared incapacitated.
- Previous enrolment in the present study.
- Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form), to prevent pregnancy in a partner.
- Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophagi-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.
- 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.
- Untreated active hepatitis. In case of detectable viral HBV load, appropriate treatment should be instituted.
- Transjugular intrahepatic portosystemic shunt (TIPS).
- Body weight over 150 kg (because of maximum table load).
- Severe allergy for intravenous contrast used (Visipaque®)
- Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
- 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.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma; a Multi-centre, Interventional, Non-randomized, Non-comparative, Open Label, Early Phase II Study
The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:
- What is the safety and toxicity profile of the 166-Holmium microspheres?
- Is the device effective in treating HCC?
Read more
Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:
- A Computed Tomography (CT) scan
- A Magnetic Resonance Imaging (MRI) scan
- Blood tests
- Quality of life questionnaires
Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- 166Holmium microspheres (QuiremSpheres®)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
166Holmium microspheres (QuiremSpheres®)Device
QuiremSpheres® are a biocompatible microsphere that contain the radionuclide holmium-166 (166Ho), which emits gamma-radiation (81 keV) and high-energy (1.81 MeV) beta-particles.
| Study group | Role | What they receive |
|---|---|---|
| Radioembolisation with 166Holmium microspheres | Experimental | Not described Receives: Device: 166Holmium microspheres (QuiremSpheres®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0.
Measured: Approximately 8 months
Secondary outcomes (1)
The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria.
Measured: Approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start22 Feb 2024
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Why it stopped: Terumo Europe NV permanently discontinued production of Holmium platform SIRT product range
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Europe N.V.
- Responsible party
- Sponsor
- Investigators
- Rohini Sharma, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302400
- Sponsor's protocol ID
- RS-IC04
- Acronym
- RHEPaiR
- Status last verified
- Sep 2025
- First submitted
- 6 Feb 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qurashi M, Martinez M, Ward C, Wyard C, Izadi H, Bowen C, Khan SR, Tait P, Smits M, de Bruijne J, Thomas R, Lam MGEH, Sharma R. Individualised dosimetry for holmium-166 RE in patients with unresectable hepatocellular carcinoma; a multi-centre, interventional, non-randomised, non-comparative, open label, phase II study: RHEPaiR. BMJ Open. 2025 Nov 19;15(11):e097066. doi: 10.1136/bmjopen-2024-097066.
PubMed 41263849
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma; a Multi-centre, Interventional, Non-randomized, Non-comparative, Open Label, Early Phase II Study
- ClinicalTrials.gov ID
- NCT06302400
- Acronym / sponsor ID
- RHEPaiR / RS-IC04
- Conditions
- Carcinoma, Hepatocellular
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terumo Europe NV permanently discontinued production of Holmium platform SIRT product range
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Terumo Europe N.V.
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 8 Mar 2024 (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.
The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are:
- What is the safety and toxicity profile of the 166-Holmium microspheres?
- Is the device effective in treating HCC?
Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including:
- A Computed Tomography (CT) scan
- A Magnetic Resonance Imaging (MRI) scan
- Blood tests
- Quality of life questionnaires
Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioembolisation with 166Holmium microspheres | Experimental | Device: 166Holmium microspheres (QuiremSpheres®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provided written informed consent.
- Female or male aged 18 years and over.
- Diagnosis of HCC established according to AASLD criteria: nodule >1 cm in a patient at risk for HCC, with combination of arterial hypervascularity and venous or delayed phase wash-out on multiphase CT-scan or MRI-scan. LR-5 and LR- 4 based on Liver Imaging Reporting and Data System can be included.
- No curative treatment options (resection, transplant, or in case of solitary tumour, RFA).
- Life expectancy of at least 6 months.
Key exclusion criteria (22 listed)
- Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening).
- Hepatic radiation therapy within the last 4 weeks before the start of study therapy.
- Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with systemic treatment are allowed.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Serum bilirubin > 34 umol/L in the absence of a reversible cause
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 |
|---|---|---|
| 166Holmium microspheres (QuiremSpheres®)QuiremSpheres® are a biocompatible microsphere that contain the radionuclide holmium-166 (166Ho), which emits gamma-radiation (81 keV) and high-energy (1.81 MeV) beta-particles. | Device | Radioembolisation with 166Holmium microspheres |
Primary outcome
The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0.
Time frame: Approximately 8 months
1 secondary outcome
The rate of efficacy as defined as overall response rate (ORR) in patients receiving individualized treatment with 166Ho- microspheres, using modified RECIST (mRECIST) response evaluation criteria.
Time frame: Approximately 8 months
Results and safety
The study was stopped early (reason given: Terumo Europe NV permanently discontinued production of Holmium platform SIRT product range). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 41263849Qurashi M, Martinez M, Ward C, Wyard C, Izadi H, Bowen C, Khan SR, Tait P, Smits M, de Bruijne J, Thomas R, Lam MGEH, Sharma R. Individualised dosimetry for holmium-166 RE in patients with unresectable hepatocellular carcinoma; a multi-centre, interventional, non-randomised, non-comparative, open label, phase II study: RHEPaiR. BMJ Open. 2025 Nov 19;15(11):e097066. doi: 10.1136/bmjopen-2024-097066.
- 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.
Rohini Sharma, Professor principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 166Holmium microspheres (QuiremSpheres®) in people with Carcinoma, Hepatocellular, run by Imperial College London at 1 site in United Kingdom.
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 10 inclusion and 22 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: stopped early, as of the sponsor's last update on 19 Sep 2025. 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 United Kingdom. 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 was stopped early (reason given: Terumo Europe NV permanently discontinued production of Holmium platform SIRT product range). 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?
The incidence of adverse and serious adverse events in patients receiving individualized treatment with 166Ho- microspheres, using National Cancer Institute CTCAE v5.0. (time frame: Approximately 8 months). 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 NCT06302400, which also lists 1 linked publication.
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 19 Sep 2025.