Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02883153|
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Zirconium-89 girentuximab PET/CT||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Zirconium-89-girentuximab PET/CT Imaging in Patients Suspected of Primary or Relapse Clear Cell Renal Cell Carcinoma: The Impact on Clinical Decision Making.|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||June 6, 2017|
|Actual Study Completion Date :||June 6, 2017|
Experimental: Zirconium-89 girentuximab PET/CT
A Zirconium-89-girentuximab PET/CT will be performed 4-5 days after single intravenous injection of 5 mg Zirconium-89-girentuximab (37 MBq).
Drug: Zirconium-89 girentuximab PET/CT
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.
Other Name: girentuximab
- Impact on clinical decision making [ Time Frame: 1 year ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883153
|Principal Investigator:||Wim JG Oyen, MD||Radboud University|
|Principal Investigator:||Peter FA Mulders, MD||Radboud University|