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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