An interventional study of 89Zr-TLX250 PET/CT in Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc) and Neuroendocrine Tumors, sponsored by Nantes University Hospital. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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- 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 .
Exclusion Criteria:
Patients will be injected with a single dose of 89Zr-TLX250.
Radiation: 89Zr-TLX250 PET/CT
Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
Tumor targeting of 89Zr-TLX250 PET
Number of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
Time frame: Day 5
Tumor targeting of 89Zr-TLX250 PET
Location of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
Time frame: Day 5
Evaluation of tolerability
Unexpected immediate adverse events up to post-administration of 89Zr-TLX250.
Time frame: Hour 2
Evaluation of tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 8
Diagnostic efficacy
Sensitivity of 89Zr-TLX250 PET/CT in the detection of tumor lesions as compared to a composite truth standard (determined on the basis of histology and conventional morphological or PET imaging).
Time frame: Month 3
Diagnostic efficacy
Concordance of 89Zr-TLX250 PET/CT in the detection of tumor lesions as compared to a composite truth standard (determined on the basis of histology and conventional morphological or PET imaging).
Time frame: Month 3
Assessment of tumor uptake
Tumor quantitative measures on 89Zr-TLX250 PET.
Time frame: Day 8
Correlation with CAIX
Assessment of the correlation between the normalized uptake values (SUVmax) of 89Zr-TLX250 positive lesions and CAIX histological expression will be done by comparing the 89Zr-TLX250 semi-quantitative data with the immunohistochemical results (IHC) of biopsied lesions.
Time frame: Day 8
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Time frame: Day 0
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Time frame: Day 1
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Time frame: Day 5
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Time frame: Day 7
Plan to share: Undecided
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