89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Kidney Cancer
Unknown Primary
18 Years and older, Male and Female
89Zr-TLX250-003 (primary)
NCI-2020-02184
Summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell
renal cell carcinoma.
Objectives
This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate
sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed
Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC)
in adult patients with indeterminate renal masses (IRM), scheduled for partial or total
nephrectomy.
Patients, will be recruited in 12-15 renal cancer care specialist centres, who have
access to state-of-the-art PET/CT imaging equipment.
The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted
5 +/-2 days post administration. The partial/total nephrectomy will then be performed at
institutional discretion any time following the PET/CT imaging visit, but no later than
90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared
and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a
central laboratory.
On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be
obtained. In patients, in which unexpected evidence for disseminated disease is observed,
PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at
the discretion of the investigator.
Image data analyses will be performed by a central image core lab. Qualitative visual
analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of
renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test
performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using
histological results from the central histological reference laboratory as standard of
truth.
Eligibility
- 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
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