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Trial record 2 of 10 for:    stem cell kidney | ( Map: Netherlands )

Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883153
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE August 25, 2016
First Posted Date  ICMJE August 30, 2016
Last Update Posted Date June 19, 2017
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date June 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02883153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma
Official Title  ICMJE Zirconium-89-girentuximab PET/CT Imaging in Patients Suspected of Primary or Relapse Clear Cell Renal Cell Carcinoma: The Impact on Clinical Decision Making.
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Drug: Zirconium-89 girentuximab PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 6, 2017
Actual Primary Completion Date June 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In order to participate in this study, a subject must meet all of the following criteria:

  1. His or her clinician should face a diagnostic dilemma; e.g.

    • patients with a renal mass of unknown origin, or
    • patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or
    • patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease.
  2. Minimum age 18 years
  3. Signed informed consent

Exclusion Criteria:

  • History of a CAIX-negative or non clear cell RCC.
  • Administration of tyrosine kinase inhibiters within 1 month prior to inclusion.
  • Any medical condition present that in the opinion of the investigator will affect patients' clinical status. - Administration of a radioisotope within 10 physical half lives prior to study enrollment
  • Pregnancy or lactation.
  • Known hypersensitivity or HACA (human anti chimeric antibodies) against Girentuximab.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02883153
Other Study ID Numbers  ICMJE 08121986
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data will be published anonymously
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wim JG Oyen, MD Radboud University
Principal Investigator: Peter FA Mulders, MD Radboud University
PRS Account Radboud University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP