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CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease

NCT07171905 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-03-09

No results posted yet for this 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.

Conditions

  • VHL - Von Hippel-Lindau Syndrome

Interventions

DRUG

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.

Sponsors & Collaborators

  • IRCCS Ospedale San Raffaele

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07171905 on ClinicalTrials.gov