A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)
- Conditions
- clear cell renal carcinoma - kidney cancer10038364
- Registration Number
- NL-OMON52858
- Lead Sponsor
- TELIX International Pty Ltd - Françoise Bruyère
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
- Male or female >= 18 years of age
- Imaging evidence of a single indeterminate renal mass of <= 7 cm in largest
diameter (tumour stage cT1), on standard of care imaging, based on national
standards, not older than 90 days on Day 0, but performed before any screening
procedure.
- Scheduled for lesion resection as part of regular diagnostic work-up within
90 days from planned 89Zr-TLX250 administration.
- Sufficient life expectancy to justify nephrectomy.
- Consent to practise highly effective contraception until a minimum of 42 days
after 89Zr-TLX250 administration.
- A biopsy procedure only (rather than 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
89Zr-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
- Known hypersensitivity to girentuximab or DFO (desferoxamine)
- Renal insufficiency with GFR <= 45 mL/min/ 1.73 m²
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Sensitivity and Specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Further test performance parameters<br /><br>- Standardized uptake value (SUV)<br /><br>- Inter-reader variability<br /><br>- Safety<br /><br>- Exploratory Variable</p><br>