Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
Inclusion Criteria:
- Histological or cytological confirmed solid tumour, primary or secondary stage IV
and/ or tumours with no curative treatment options
- WHO performance status 0 to 1
- Normal white blood cell count and formula
- Normal platelet count
- No anaemia requiring blood transfusion or erythropoietin
- Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for
the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution)
- Calculated Creatinin clearance at least 60 ml/min
- No administration of Fluor-18 in the previous 24 hours
- The patient is capable of complying with study procedures
- 18 years or older
Exclusion Criteria:
- Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the
liver, stomach and the kidneys would interfere with image quality of the tumor)
- Known hypersensitivity for sulfonamides
- Recent (< 3 months) myocardial infarction
- Uncontrolled infectious disease
- Less than 18 years old
- Pregnancy
- No concurrent anti-cancer agents or radiotherapy allowed