CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
investigating the role of CAIX as target in VHL disease and in VHL-/- tumors.: Participants VHL disease and in VHL-/- tumors, will receive a single dose of the diagnostic radiopharmaceutical \[89Zr\]Zr-DFO-Girentuximab and subsequently undergo imaging with a hybrid PET/CT scanner.
Study summary
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.
Eligibility
Primary outcome measure(s)
- to assess the efficacy of CAIX-PET — IMP administration at day 0; CAIX-PET from day 3 to 7; MRI according to standard of care and imaging assessment from day 1 to 60.
to assess the Sensitivity of CAIX-PET for the diagnosis of tumors in VHL disease
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele | Milan | Italia | Recruiting |
More IRCCS Ospedale San Raffaele trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07171905 on ClinicalTrials.gov ↗ ← All trials in Italy