Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
89Zr-Girentuximab · 4 trials · 5 indications
This outcome was evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This was compared against the histological determination of the lesion type following resection of the lesion
Sensitivity and specificity will be established following histological confirmation
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the physical examination.
Frequency of occurrence and severity of abnormal findings in safety investigations regarding the Vital signs
Frequency of occurrence and severity of abnormal findings in safety investigations regarding Laboratory examinations.
Frequency of occurrence and severity of abnormal findings in safety investigations regarding concomitant medications.
Frequency of occurrence and severity of abnormal findings in the 12-lead ECG (ECG QT Interval)
Incidence of abnormal laboratory test results and abnormal vital signs
The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.
| Arm | Type | Description |
|---|---|---|
| 89Zr-girentuximab | EXPERIMENTAL | A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration. |
| Administration of 89Zr-Girentuximab | OTHER | Administration of 89Zr-Girentuximab as per protocol |
| Name | Type | Description |
|---|---|---|
| 89Zr-girentuximab | DIAGNOSTIC_TEST | Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days. |
Inclusion Criteria: 1. Written and voluntarily given Informed Consent 2. Male or female ≥18 years of age 3. 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 4. Scheduled for lesi...