PET/CT with zirconium‑labelled girentuximab to image CAIX in liver and gastro‑entero‑pancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses 89Zr‑labelled girentuximab as an immunoPET tracer targeting carbonic anhydrase IX (CAIX) to image HCC, ICC and selected GEP‑NEN patients. Eligible adults with at least one RECIST‑measurable lesion and ECOG 0–2 will receive a PET/CT with the tracer to determine tumor uptake and distribution. The design includes baskets for HCC/ICC and for progressive or specific GEP‑NEN subgroups to capture heterogeneous expression patterns. Imaging findings could inform lesion detection, staging, and potential selection for future CAIX‑targeted theranostic approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Nantes
  Nantes, France Recruiting
• AP-HP - Site de Beaujon
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Clément BAILLY
• Email: clement.bailly@chu-nantes.fr
• Phone: +33240084136

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.