Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: Nantes University Hospital
You may qualify if…
- ✓ 1. Provided written informed consent.
- ✓ 2. Patients aged ≥ 18 years.
- ✓ 3. \- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.
- ✓ \- For basket 3: Progressive GEP-NENs with low or heterogeneous expression of SSTR2 or progressive pancreatic NENs which previously received at least two systemic treatments (excluding SSA) or pancreatic NENs with germline or somatic VHL mutation or G3 GEP-NENs .
- ✓ 4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
- ✓ 5. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
- ✓ 6. For cirrhotic patients: Child-Pugh ≤ B7.
- ✓ 7. Patient affiliated to or beneficiary of the National Health Service.
You may not qualify if…
- ✕ 1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
- ✕ 2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
- ✕ 3. Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
- ✕ 4. Radioembolization within 3 months prior to inclusion.
- ✕ 5. Uncontrolled brain or spinal cord metastasis.
- ✕ 6. Cardiac disease with New York Heart Association classification of III or IV.
- ✕ 7. Life expectancy shorter than 4 months.
- ✕ 8. Any major surgery within 4 weeks before enrollment.
Source: ClinicalTrials.gov · NCT06735560 · last updated 2026-05-13