89Zr-TLX250 for PET/CT Imaging of ccRCC - ZIRCON-CP Study
ConditionClear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Limited
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 89Zr-TLX250 PET/CT
Treatment groups
82 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov