Radiation beads aim to shrink liver tumors in neuroendocrine cancer trial
NCT ID NCT04362436
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a treatment called TheraSphere selective internal radiation therapy (SIRT) in 24 patients with neuroendocrine tumors that had spread to the liver and could not be surgically removed. The treatment involves injecting tiny radioactive beads into the liver's blood supply to deliver radiation directly to tumors. The study measured safety, tumor shrinkage, and how long patients lived without their disease getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TheraSphere (yttrium-90 glass microspheres) for selective internal radiation therapy
- What this could lead to
- If successful, this could offer a new treatment option for patients with inoperable liver metastases from neuroendocrine tumors, potentially improving tumor control and survival.
- What could go wrong
- This is a small, early-phase trial with only 24 participants, so results may not apply broadly. Radiation to the liver carries risks of liver damage, fatigue, and other 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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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24 people
The number who actually took part.
- Started
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Feb 2019
- Finished
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Aug 2023
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: All patients must be discussed at a specialist hepatobiliary multi-disciplinary team meeting (MDT) and meet the following criteria: * Histologically confirmed neuroendocrine tumour, with documented grade. * \>18 years of age * Patients may be on SSAs concurrently.Patients must have had at least one previous line of therapy * Unresectable liver only or liver predominant metastases (typically involving \>25% but \<60% of the liver, and technically inoperable, or unfeasible secondary to medical comorbidity) * Have measurable disease by RECIST 1.1 criteria * Life expectancy of \>12 weeks * Eastern Cooperative Oncology Group (ECOG) / World Health Organisation (WHO) Performance Status of 0-1 * Adequate liver function (bilirubin less than 34 umol/L in the absence of a reversible cause) * Blood work: patients must have * Platelet count of \> or = to 50x10\^9/L * Hb of \> or = to 8.5g/dL * Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) \< 5 x Upper limit of normal (ULN) * Serum creatinine \< 1.5 x ULN * Internal Normalised Ration (INR) \< 2.0 * Patients with portal vein thrombosis may be considered, as determined at MDT (A compromised main portal vein as demonstrated on triple-phase CT scan unless selective or super-selective SIRT can be performed and the other safety criteria are fulfilled) Exclusion Criteria: Patients who meet any of the following exclusion criteria will NOT be considered eligible for this study. * Clinically apparent ascites or other signs of hepatic failure on physical examination * Severe uncontrollable coagulopathy * No safe vascular access to the liver, as determined by triple phase CT * Potential for excess radiation exposure (\>30Gy) to the lungs, as determined by pretreatment 99mTc-MAA lung shunt (\>20% shunt) * Shunting to the GI tract that cannot be corrected by embolization, as demonstrated by hepatic angiogram * Previous Transarterial chemoembolization (TACE) or SIRT * Multiple biliary stents, or ongoing cholangitis, or any intervention for, or compromise of, the Ampulla of Vater * Previous external bean radiotherapy to the liver * Systemic anti-cancer therapy within the last 4 weeks (excluding 1st line therapy with SSA) * Treatment with Vascular endothelial growth factor (VEGF) inhibitors within 3 months prior to therapy * Previous or concurrent cancer, other than Basal Cell Carcinoma, unless treated curatively 5 or more years prior to entry * Tumour involvement of \>60% of the liver * Oesophageal bleeding during the last 3 months * Any history of hepatic encephalopathy * Transjugular intrahepatic portosystemic shunt (TIPS) * Must not be at risk of hepatic or renal failure * Contraindications against angiography * Pregnancy and breast feeding. Women of child-bearing potential must have a negative pregnancy test 14 days before treatment, and at the time of theresphere administration. * Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. * Must not be participating in concurrent clinical trials evaluating treatment intervention(s).
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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 NHS Trust
London, W12 0HS, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can patient records reveal who will respond to neuroendocrine tumor treatments?