The study is a phase 2, non-comparative and non-randomized, single arm, national clinical trial testing the hypothesis that CAIX-PET has diagnostic and theranostic potential in VHL disease and in VHL-/- tumors. Participants will receive a single dose of the diagnostic radiopharmaceutical \[89Zr\]Zr-DFO-Girentuximab and subsequently will be subjected to imaging with an hybrid PET/CT scanner. Sensitivity and diagnostic accuracy of experimental imaging will be assessed against standard of truth derived from standard of care procedures such as MRI or pathology following surgery. A theranostic approach will be simulated by replacing the physical decay of the diagnostic isotope \[89Zr\]Zr with the physical decay of therapeutic isotopes and evaluating tissue dosimetry.
Voluntarily given informed consent
Age ≥18 years old
Performance Status ECOG/WHO score 0-2
For females of reproductive potential, negative pregnancy test and use of highly effective contraception for 30 days following IMP administration
Performance Status ECOG/WHO score >2
Women who are pregnant or breastfeeding or are planning pregnancy during the study
Men who are planning fatherhood during the study
Exposure to any murine or chimeric antibodies within 5 years prior to the planned IMP administration