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Table 3 Inclusion and exclusion criteria

From: Additional hepatic 166Ho-radioembolization in patients with neuroendocrine tumours treated with 177Lu-DOTATATE; a single center, interventional, non-randomized, non-comparative, open label, phase II study (HEPAR PLUS trial)

Inclusion criteria

Exclusion criteria

Patient must have given a written informed consent

Brain metastases or spinal cord compression, unless irradiated > 4 weeks prior to 166Ho-RE and stable for at least 1 week without steroids

≥ 18 years of age

Serum bilirubin > 1.5 x upper limit of normal

Confirmed histological diagnosis NET

Glomerular filtration rate < 35 ml/min

Prior treatment with 4 cycles of 7.4 GBq 177Lu-DOTATATE within 20 weeks before 166Ho-RE

Alkaline phosphatase, alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal

Life expectancy > 12 weeks

Leucocytes < 2.0 × 109/l and/or platelet count < 50 × 109/l

WHO performance score 0–2

Significant cardiac event within 3 months of inclusion

≥ 3 measurable liver lesions according to RECIST 1.1

Patients suffering from diseases with an increased chance of liver toxicity

Negative pregnancy test for women of childbearing potential

Patients declared incompetent or suffering from psychic disorders making comprehensive judgment impossible

No nursing activities for women of childbearing potential

Severe bile duct abnormalities: papillotomy, cholecystectomy, biliary stents and bilidigestive anastomosis are allowed

Acceptable method of contraception

Body weight > 150 kg

 

Severe contrast allergy

 

Liver tumour involvement > 70% on CT