CompletedPhase 3

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

United States300 participantsStarted 2019-08-15

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Sensitivity and Specificity of Qualitative Assessment of PET/CT Imaging With 89Zr-TLX250 to Noninvasively Detect ccRCC in Patients With Indeterminate Renal Masses, Using Histology as Standard of Truth.

Timeframe: Diagnostic PET/CT scan on Day 5 ± 2 days post 89Zr-TLX250 administration. Histological confirmation of the material from nephrectomy conducted within 90 days post 89Zr-TLX250 administration served as standard of truth.

Trial details

NCT IDNCT03849118

SponsorTelix Pharmaceuticals (Innovations) Pty Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-20

Results submitted2024-02-22

View on ClinicalTrials.gov More Clear Cell Renal Cell Carcinoma trials