89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

Inclusion Criteria:

Written and voluntarily given Informed Consent
Male or female ≥18 years of age
Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
for patients included in France only, verification and confirmation of their affiliation with a social security
Sufficient life expectancy to justify nephrectomy
Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

Exclusion Criteria:

Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
Renal mass known to be a metastasis of another primary tumour
Active non-renal malignancy requiring therapy during the time frame of the study participation
Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
Exposure to murine or chimeric antibodies within the last 5 years
Previous administration of any radionuclide within 10 half-lives of the same
Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
Women who are pregnant or breastfeeding
Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
Vulnerable patients (e.g being in detention)