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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2021
  • participants needed
    252
  • sponsor
    Telix International Pty Ltd
Updated on 25 October 2020
Investigator
Telix Pharmaceuticals
Primary Contact
Macquarie University Hospital (1.3 mi away) Contact
+25 other location
carcinoma
nephrectomy
clear cell renal cell carcinoma

Summary

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

Description

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.

Details
Treatment 89Zr-Girentuximab
Clinical Study IdentifierNCT03849118
SponsorTelix International Pty Ltd
Last Modified on25 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Renal Cancer or Adenocarcinoma or Renal Cell Carcinoma?
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)
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