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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
CHU de Nantes
Nantes, France
RECRUITINGAP-HP - Site de Beaujon
Paris, France
NOT_YET_RECRUITINGTumor 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
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