Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06735560

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATION89Zr-TLX250 PET/CTPatients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.

Timeline

Start date
2025-11-04
Primary completion
2027-05-04
Completion
2027-08-04
First posted
2024-12-16
Last updated
2025-12-08

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06735560. Inclusion in this directory is not an endorsement.