Radioactive beads aim to shrink untreatable liver tumors
NCT ID NCT06302400
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early trial tested the safety and effectiveness of radioactive beads (Holmium-166 microspheres) in 4 adults with liver cancer that could not be removed by surgery or transplant. Participants first received a small scout dose to check for proper placement, then a personalized therapeutic dose. The study was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Holmium-166 microspheres (radioactive beads)
- What this could lead to
- If successful, this could provide a new treatment option for liver cancer patients who cannot have surgery or transplant.
- What could go wrong
- This is a very early, small trial (only 4 participants) that was terminated, so results are limited. The treatment involves radiation, which can cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Mar 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provided written informed consent. 2. Female or male aged 18 years and over. 3. 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. 4. No curative treatment options (resection, transplant, or in case of solitary tumour, RFA). 5. Life expectancy of at least 6 months. 6. ECOG Performance status 0-1. 7. 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). 8. Child-Pugh class A5-6 or B7. 9. At least one measurable liver lesion according to the modified RECIST criteria. 10. 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. Exclusion Criteria: 1. Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening). 2. Hepatic radiation therapy within the last 4 weeks before the start of study therapy. 3. Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with systemic treatment are allowed. 4. Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy. 5. Serum bilirubin \> 34 umol/L in the absence of a reversible cause 6. Glomerular filtration rate \<35 ml/min. 7. Non-correctable INR \>1.5 in case of femoral approach (as opposed to radial). 8. Platelet count \<50 109/l. 9. 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. 10. Pregnancy or breastfeeding. 11. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression. 12. Patients who are declared incapacitated. 13. Previous enrolment in the present study. 14. 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. 15. 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. 16. 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. 17. Untreated active hepatitis. In case of detectable viral HBV load, appropriate treatment should be instituted. 18. Transjugular intrahepatic portosystemic shunt (TIPS). 19. Body weight over 150 kg (because of maximum table load). 20. Severe allergy for intravenous contrast used (Visipaque®) 21. Lung shunt \>30 Gy, as calculated using scout dose SPECT/CT. 22. Extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
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