89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study (NCT06750419) | Clinical Trial Compass
RecruitingPhase 3
89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
China82 participantsStarted 2024-11-06
Plain-language summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma, and this Phase 3 bridging study in mainland Chinese patients is intended to support the successful ZIRCON data (ZIRCON Clinicaltrial.gov ID: NCT03849118)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written and voluntarily given informed consent.
✓. Mainland Chinese male or female, aged ≥ 18 years.
✓. Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC 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 IV 89Zr-TLX250 administration.
✓. Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
✓. Sufficient life expectancy to justify nephrectomy.
✓. Consent to practise highly effective contraception until a minimum of 42 days after IV 89Zr-TLX250 administration.
Exclusion criteria
✕. A biopsy procedure only (rather than partial or total nephrectomy) is 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.
✕. Multiple unilateral or bilateral IRM.
✕
What they're measuring
1
To evaluate the sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth
Timeframe: From Visit 4 till end of study. 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
. Chemotherapy, radiotherapy, targeted therapy 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 IV 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.