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Recruiting NCT07171905

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

Phase II Interventional VHL - Von Hippel-Lindau Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: investigating the role of CAIX as target in VHL disease and in VHL-/- tumors..
Who it may be relevant to
Registry conditions: VHL - Von Hippel-Lindau Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • to assess the efficacy of CAIX-PET [Time frame: 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.]

Eligibility criteria

Inclusion 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.

And, for the primary cohort:

  • Diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test

Alternatively, 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

  • Performance Status ECOG/WHO score >2
  • 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
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT07171905 · PNRR-POC-2023-12377493

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗