Actively Recruiting
Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
Led by Nantes University Hospital · Updated on 2026-05-13
60
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Age 18 years or older
- For HCC or ICC: histologically confirmed diagnosis, newly diagnosed or suspected refractory, residual, or recurrent disease
- For GEP-NENs: progressive disease with low or mixed SSTR2 expression, or progressive pancreatic NENs after at least two systemic treatments (excluding SSA), or pancreatic NENs with VHL mutation or G3 GEP-NENs
- At least one measurable lesion by RECIST 1.1 on contrast CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- For cirrhotic patients: Child-Pugh score of B7 or less
- Affiliated to or beneficiary of the National Health Service
You will not qualify if you...
- Known allergy to zirconium-89, any excipient, or radiographic contrast agents
- Received chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks before 89Zr-TLX250 administration
- Received radionuclide targeted therapy within 3 months before inclusion
- Underwent radioembolization within 3 months before inclusion
- Uncontrolled brain or spinal cord metastasis
- Cardiac disease classified as New York Heart Association class III or IV
- Life expectancy less than 4 months
- Major surgery within 4 weeks before enrollment
- Uncontrolled significant medical or psychiatric conditions that may affect safety or compliance
- Other cancers except fully resected non-melanoma skin cancer or cervical cancer in situ unless treated and no recurrence for 2 years
- Pregnant or breastfeeding women
- Under guardianship, trusteeship, or judicial protection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
CHU de Nantes
Nantes, France
Actively Recruiting
2
AP-HP - Site de Beaujon
Paris, France
Not Yet Recruiting
Research Team
C
Clément BAILLY
CONTACT
A
Astrid GARREAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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