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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
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Zirconium-89 girentuximab PET/CT Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Netherlands
Radboudumc
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Wim JG Oyen, MD Radboud University
Principal Investigator: Peter FA Mulders, MD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02883153     History of Changes
Other Study ID Numbers: 08121986
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published anonymously
Keywords provided by Radboud University:
Zirconium-89
PET/CT
imaging
girentuximab
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs