Table 3.
Inclusion and exclusion criteria
| 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 |