Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN

Sponsor
Nantes University Hospital
Study ID
NCT06735560
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-TLX250 PET/CT — RADIATION
    Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.

Study Details

Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.

Key Dates

First listed
Dec 16, 2024
Start date
Nov 4, 2025
Status verified
May 2026
Primary completion
May 4, 2027
Completion
Aug 4, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 89Zr-TLX250
    Patients will be injected with a single dose of 89Zr-TLX250.

Primary Outcome Measure

Tumor targeting of 89Zr-TLX250 PET [ Time Frame: Day 5 ]

Central Contacts

Find similar trials

Nationwide
Neuroendocrine tumors trialsOncology trials

Related Studies