TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets

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).