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

Status
Completed
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Diagnostic
NCT ID
NCT03849118
Protocol IDs
89Zr-TLX250-003 (primary)
NCI-2020-02184
Study Sponsor
Telix International Pty Ltd

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

  1. Written and voluntarily given Informed Consent
  2. Male or female =18 years of age
  3. 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
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
  5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
  6. for patients included in France only, verification and confirmation of their affiliation with a social security
  7. Sufficient life expectancy to justify nephrectomy
  8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration
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