RecruitingNot ApplicableNCT06735560

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

Prospective Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Patients With HepatoCellular Carcinoma, IntraHepatic CholangioCarcinoma or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms

Sponsor

Nantes University Hospital

Enrollment

60 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Neuroendocrine Tumors Hepatocellular Carcinoma (HCC)Intrahepatic Cholangiocarcinoma (Icc)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET scan imaging agent called zirconium-labelled girentuximab to see if it can better detect and monitor liver cancer (HCC), bile duct cancer (ICC), and certain neuroendocrine tumors (NENs) in the body. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with liver cancer (HCC), bile duct cancer (ICC), or a gastroenteropancreatic neuroendocrine tumor (GEP-NEN) - You are newly diagnosed or suspected of having recurrent or residual disease - You have at least one lesion visible on standard CT or MRI imaging **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have severe kidney problems that prevent safe imaging - You have known allergies to the imaging agent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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