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CAT-VHL - Exploring the role of Carbonic Anhydrase IX as diagnostic and Theranostic target in Von-Hippel Lindau disease
EU CTIS ID: 2024-515679-36-01
What this study is testing
To explore the role of Carbonic Anhydrase IX as diagnostic and theranostic target in Von-Hippel Lindau disease.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration
- For the Primary Cohort: diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test
You likely can't join if
- Performance Status ECOG/WHO score >2
- Known hypersensitivity to [89Zr]Zr-DFO-Girentuximab or DFO (Desferrioxamine)
- Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL/min/1.73m2
- Other vulnerable categories than rare disease (e.g, being in detention)
- Women who are pregnant or breastfeeding or are planning pregnancy during the study
- Men who are planning fatherhood during the study
See the full eligibility criteria
- 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
- For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration
- For the Primary Cohort: diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test
- For the Secondary Cohort: clinical and/or pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor or clear cell renal cell carcinoma requiring surgery
- Performance Status ECOG/WHO score >2
- Known hypersensitivity to [89Zr]Zr-DFO-Girentuximab or DFO (Desferrioxamine)
- Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL/min/1.73m2
- Other vulnerable categories than rare disease (e.g, being in detention)
- 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
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the planned IMP administration
- Surgery, biopsy, ablative procedure, radiotherapy or any other local treatment for any primary tumor within 4 weeks prior to the planned IMP administration
- 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
- Current exposure to systemic agents or scheduled therapy in the next 6 months following the planned IMP administration
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.