SYF0c8c7c63c75b49809742b7e55db588dc

Not Yet RecruitingPhase 2

CAT-VHL - Exploring the role of Carbonic Anhydrase IX as dia...

Ospedale San Raffaele S.r.l.Source

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

2

Brief Summary

To explore the role of Carbonic Anhydrase IX as diagnostic and theranostic target in Von-Hippel Lindau disease.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: not yet recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 30, 2025
Actual (reported)

Conditions

Von-Hippel Lindau (VHL) Disease

Outcome Measures

Primary Outcomes (1)

To evaluate the efficacy of CAIX-PET for the detection of tumors in patients with VHL disease.

Secondary Outcomes (3)

To evaluate the diagnostic accuracy of CAIX-PET in VHL -/- tumors diagnosed in the sporadic setting.
To evaluate the diagnostic accuracy of CAIX-PET in VHL disease.
To evaluate the safety of CAIX-PET.

Interventions

Zr-DFO-girentuximabType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily given informed consent
Age ≥18 years old
Performance Status ECOG/WHO score 0-2

Sponsors & Collaborators

Ospedale San Raffaele S.r.l.
Type not reportedlead

Study Sites (2)

Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona

Salerno, 84131, Italy

Paolo Verze089672577 pverze@unisa.it

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Alessandro Larcher0226434121 larcher.alessandro@hsr.it

Central Study Contacts

Alessandro Larcher

+390226434121 larcher.alessandro@hsr.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

May 30, 2025

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-515679-36-01
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 05:24:21 UTC

Documents

K1_Recruitment arrangements

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.

L1_SIS and ICF adults_for pubblication

L1_SIS adults_privacy_for pubblication

L2_Other subject information material_URBBAN consent_for pubblication

L2_Other subject information material_family doctor letter

L2_Other subject information material_patient card

L2_Other subject information material_URBBAN consent intro_for publication

L2_Other subject information material_URBBAN privacy_for publication

D1_Protocol_2024-515679-36-01_for pubblication

D1_Protocol Signature Page_2024-515679-36-01

D1_Protocol Synopsis_ENG_2024-515679-36-01_for pubblication

D1_Protocol Synopsis_ITA_2024-515679-36-01_for pubblication

E1_IB 89Zr-TLX250_V12-1_20-OCT-25_redacted

Locations

IT(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations