Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06447103 | An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer | PHASE2 | RECRUITING | 91 | — | — | Aug 6, 2024 | Dec 1, 2030 | Jun 12, 2025 | 1 | United States |
Patients will be treated as binary categorization as follows: (i) Patients who have ≥ 1 lesion confirmed to be recurrent disease will be designated positive (recurrence). (ii) Patients with no lesions detected will be designated negative (no recurrence). The analysis of the primary objective will utilize McNemar's test to compare the detection rate between the imaging techniques.
| Arm | Type | Description |
|---|---|---|
| Diagnostic (89Zr-DFO-GmAb PET/CT) | EXPERIMENTAL | Patients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and SOC diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or MRI of the brain on study as clinically indicated. |
| Name | Type | Description |
|---|---|---|
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Scan | PROCEDURE | Undergo bone scan |
| Computed Tomography | PROCEDURE | Undergo CT, PET/CT, and CT of the brain |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI of the brain |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Questionnaire Administration | OTHER | Ancillary studies |
| Zirconium Zr 89 Girentuximab | DRUG | Given IV |
Inclusion Criteria: * Age ≥ 18 * Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy) * For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumo...