Actively Recruiting
CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease
Led by IRCCS Ospedale San Raffaele · Updated on 2026-03-09
38
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily given informed consent
- Age 18 years or older
- 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 radiopharmaceutical administration
- For males of reproductive potential, use of highly effective contraception for 30 days following radiopharmaceutical administration
- Diagnosis of VHL disease requiring surveillance confirmed by genetic testing
- Alternatively, clinical or pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor, or clear cell renal cell carcinoma requiring surgery
You will not qualify if you...
- Performance Status ECOG/WHO score greater than 2
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Men planning fatherhood during the study
- Exposure to any murine or chimeric antibodies within 5 years prior to planned radiopharmaceutical administration
- Exposure to any experimental diagnostic or therapeutic drug within 30 days prior to planned radiopharmaceutical administration
- Surgery, biopsy, ablative procedure, radiotherapy, or other local treatment for any primary tumor within 4 weeks prior to planned radiopharmaceutical administration
- Exposure to systemic agents within 4 weeks prior to planned radiopharmaceutical administration or ongoing adverse effects greater than grade 1 from such therapy
- Current exposure to systemic agents or scheduled therapy in the 6 months following planned radiopharmaceutical administration
- Serious non-malignant diseases that may interfere with study objectives or safety, as judged by the investigator
- Known hypersensitivity to [89Zr]Zr-DFO-Girentuximab or DFO (Desferrioxamine)
- Severe chronic kidney disease with glomerular filtration rate less than or equal to 30 mL/min/1.73m2
- Other vulnerable categories besides rare disease, such as being in detention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italia, Italy, 20132
Actively Recruiting
Research Team
A
Alessandro Larcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here