Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Provided written informed consent.
Patients aged ≥ 18 years.
- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.
Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
Disqualifiers
Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
Radioembolization within 3 months prior to inclusion.
Trial design
Design model
Single group
Treatments tested in this trial
89Zr-TLX250 PET/CT
RadiationPatients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: 89Zr-TLX250Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 52
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 5Secondary outcomes
1
Evaluation of tolerability
Unexpected immediate adverse events up to post-administration of 89Zr-TLX250.
Time frame
Hour 22
Evaluation of tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
Day 83
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 34
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 3Sponsors and contacts
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Source ClinicalTrials.gov