NCT06735560 Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
| NCT ID | NCT06735560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2027-05-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-11-04 with a primary completion date of 2027-05-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 9. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study. 10. Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years. 11. Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential. 12. Patient under guardianship or trusteeship. 13. Patient under judicial protection.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06735560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06735560 currently recruiting?
Yes, NCT06735560 is actively recruiting participants. Contact the research team at clement.bailly@chu-nantes.fr for enrollment information.
Where is the NCT06735560 trial being conducted?
This trial is being conducted at Nantes, France, Paris, France.
Who is sponsoring the NCT06735560 clinical trial?
NCT06735560 is sponsored by Nantes University Hospital. The trial plans to enroll 60 participants.
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