At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
89Zr-girentuximabother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses
Telix Pharmaceuticals (Innovations) Pty Limited·interventional·Posted Feb 21, 2019·Updated May 17, 2024
In Brief
A Phase 3 clinical trial evaluating 89Zr-girentuximab for Clear Cell Renal Cell Carcinoma. Completed, enrolled 300 participants across 31 sites in 8 countries.
Detailed Summary
89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClear Cell Renal Cell Carcinoma
CountriesAustralia, Belgium, Canada, France, Netherlands, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartAug 2019
Primary CompletionOct 2022
Study CompletionNov 2022
TodayJul 2026
First PostedFeb 21, 2019
Enrollment StartAug 15, 2019
Primary CompletionOct 20, 2022
Study CompletionNov 7, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.4 years ago
Interventions
89Zr-girentuximabother
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.