To determine if disease associated lesions in patients with VHLD can be visualized with 89Zr-bevacizumab PET scans.
Conditions
Interventions
Product Name: 89Zr-SucDf-bevacizumab
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •clinically or genetically proven VHLD •at least 1 measurable, VHL associated lesion on MRI •routine MRI of the CNS and upper abdomen = 4 weeks before inclusion •age = 18 years •written informed consent must be given according to good clinical practice (GCP), and local regulations Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •pregnancy •any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, those conditions should be discussed with the patient before registration in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if disease associated lesions in patients with VHLD can be visualized with 89Zr-bevacizumab PET scans.;Secondary Objective: •To explore if 89Zr-bevacizumab PET imaging can differentiate progressive from non-progressive lesions in patients with VHLD. •To explore relationships between angiogenesis related biomarkers and endothelial activation markers and 89Zr-bevacizumab PET uptake. ;Primary end point(s): The primary endpoint is the detection rate of VHL associated lesions with 89Zr-bevacizumab PET scans in patients with VHLD. | — |
Countries
Netherlands
Outcome results
None listed