Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.
More advanced imaging methods are needed to reliably distinguish benign small renal masses (SRM) from renal cell carcinoma (RCC) to prevent invasive biopsies or unnecessary surgery. Similarly, improved imaging methods are needed for unambiguous detection of lesions suspect for metastatic and relapse RCC during follow-up. Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients. Thirty patients will be included in whom conventional diagnostics are inconclusive. During a multidisciplinary team (MDT) the hypothetical next step in the clinical process will be noted (e.g. further diagnostics, treatment or active surveillance). Subsequently, in these patients a Zirconium-89-girentuximab PET/CT will be performed. Patients will receive a single intravenous dose of 5 mg Zirconium-89-girentuximab (37 MBq). A PET/CT scan will be acquired 4 or 5 days after injection. The Zirconium-89-girentuximab PET/CT will be read by a clinician with extensive experience in radiolabeled girentuximab imaging. The results of the PET/CT will be discussed during the MDT and will be used to decide what the next step in the clinical process will be. This step will be compared with the hypothetical next step from the MDT before the scan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Thirty patients (suspected of ccRCC) will be included in whom conventional diagnostics are inconclusive. During a multidisciplinary team (MDT) the hypothetical next step in the clinical process will be noted. Subsequently, in these patients a Zirconium-89-girentuximab PET/CT will be performed 4-5 days after single intravenous injection of 5 mg Zirconium-89-girentuximab (37 MBq). The results of the PET/CT will be discussed during the MDT and will be used to decide what the next step in the clinical process will be. This step will be compared with the hypothetical next step from the MDT before the scan. Whether or not the PET/CT scan had impact on clinical decision making will be assessed for each individual patient.
Radboudumc
Nijmegen, Netherlands
Impact on clinical decision making
Impact on clinical decision making, defined as present or absent: * Absent: e.g. no change in treatment or follow-up * Present: e.g. change in follow-up schedule, change in surgical technique, change from surgery to active surveillance, or change from surgery to systemic treatment.
Time frame: 1 year
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