ZIRCONIUM (89ZR) GIRENTUXIMAB for Von Hippel-Lindau disease

Inclusion criteria

• {"criterion_text":"- Voluntarily given informed consent\n- Age ≥18 years old\n- Performance Status ECOG/WHO score 0-2\n- For females of reproductive potential, negative pregnancy test and use of highly effective contraception for 30 days following IMP administration\n- For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration\n- For the Primary Cohort: diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test\n- For the Secondary Cohort: clinical and/or pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor or clear cell renal cell carcinoma requiring surgery"}

Exclusion criteria

• {"criterion_text":"- Performance Status ECOG/WHO score >2\n- Known hypersensitivity to [89Zr]Zr-DFO-Girentuximab or DFO (Desferrioxamine)\n- Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL/min/1.73m2\n- Other vulnerable categories than rare disease (e.g, being in detention)\n- Women who are pregnant or breastfeeding or are planning pregnancy during the study\n- Men who are planning fatherhood during the study\n- Exposure to any murine or chimeric antibodies within 5 years prior to the planned IMP administration\n- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the planned IMP administration\n- Surgery, biopsy, ablative procedure, radiotherapy or any other local treatment for any primary tumor within 4 weeks prior to the planned IMP administration\n- Exposure to any systemic agent within 4 weeks prior to the planned IMP administration or in case of continuing adverse effects with grade >1 from such therapy\n- Current exposure to systemic agents or scheduled therapy in the next 6 months following the planned IMP administration\n- Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator"}

Primary endpoints

• {"endpoint_text":"- To evaluate the efficacy of CAIX-PET for the detection of tumors in patients with VHL disease.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- To evaluate the diagnostic accuracy of CAIX-PET in VHL -/- tumors diagnosed in the sporadic setting.\n- To evaluate the diagnostic accuracy of CAIX-PET in VHL disease.\n- To evaluate the safety of CAIX-PET.","definition_or_measurement_approach":""}

Italy

Earliest CTIS Part Ii Submission Date

14-08-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

244

Number Of Sites

2

Number Of Participants

38

Primary sponsor

Full Name

Ospedale San Raffaele S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy