Status:
UNKNOWN
TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Biocompatibles UK Ltd, a BT International group company
Conditions:
Neuroendocrine Tumors
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label study for patients with inoperable metastatic neuroendocrine liver deposits to see whether treatment with Selective Internal Radiation Therapy (TheraSpheres) could lead to improv...
Detailed Description
Neuroendocrine tumours (NETs) are tumours which arise from cells of the neuroendocrine system, which is the mechanism by which the hypothalamus maintains homeostasis. Neuroendocrine cells secrete horm...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04362436
Start Date
January 24 2019
End Date
September 30 2024
Last Update
March 9 2022
Active Locations (1)
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1
Imperial College NHS Trust
London, United Kingdom, W12 0HS