Objective: To assess the impact of zirconium-89-girentuximab PET/CT on clinical decision making in patients suspected of primary, recurrent or metastatic clear cell renal cell carcinoma.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, be
more certain of your treatment strategy, change from surgery to active
surveillance, or change from surgery to systemic treatment.
Secondary outcome
The amount of biopsies or surgery that are prevented by
zirconium-89-girentuximab PET/CT.
*
Background summary
Conventional imaging studies cannot reliably distinguish benign solid lesions
from renal cell carcinoma (RCC) [1-4]. So, more advanced imaging methods are
needed, to prevent invasive biopsies or unnecessary surgeries. Similarly, for
unambiguous detection of lesions suspect for metastatic and relapse RCC during
follow-up imaging methods need to be improved. Currently, SPECT/CT imaging
using Indium-111-labeled girentuximab is used for this purpose. Girentuximab is
an antibody that recognizes Carbonic Anhydrase IX (CAIX) on the cell surface of
clear cell renal cell carcinomas (ccRCC). The high sensitivity and specificity
of radiolabeled girentuximab to detect ccRCC have been confirmed in multiple
studies [5-7]. Thus, radiolabeled girentuximab is used as a valuable and
noninvasive tool in clinical decision making. Combining the superior
characteristics of PET (high resolution) with the use of the residualizing
radionuclide Zirconium-89 are major steps forward in the development of this
imaging biomarker. Although the accuracy of radiolabeled girentuximab has been
studied extensively, the impact on clinical decision making has not been
studied before. For implementation of radiolabeled girentuximab into clinical
practice, the scan should have impact on clinical decision making. Our
hypothesis is that zirconium-89-PET/CT imaging has an important impact on
clinical decision making in patients suspected of primary, recurrent or
metastatic renal cancer in whom conventional diagnostics are inconclusive.
Study objective
Objective: To assess the impact of zirconium-89-girentuximab PET/CT on
clinical decision making in patients suspected of primary, recurrent or
metastatic clear cell renal cell carcinoma.
Study design
Study design: This is a single center, single arm and open label study.
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 acquired. 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 interpreted 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. For the individual patient
will be recorded whether or not the PET/CT scan had impact on clinical decision
making. Independently of the result of PET/CT imaging patients will remain
under close follow-up (standard of care). After one year of follow-up an
post-hoc analysis will be performed to evaluate the clinical decision based on
the PET/CT. For this purpose data of follow-up imaging and histological data
will be used.
Intervention
Administration of 5 mg/37 MBq zirconium-89-girentuximab followed by PET/CT
after 4 days.
Study burden and risks
The burden of study participation is low, since it only consists of a tracer
injection and a PET/CT. The risks associated with the antibody injection are
low. Worldwide girentuximab has been administered intravenously to more than
2,500 patients and adverse reactions have never been observed. The mean
effective dose after administration of a Zirconium-89-labeled monoclonal
antibody is 0.6 mSv/MBq [8]. Effective radiation dose of 37 MBq 89Zr*labeled
girentuximab will be approximately 22 mSv. Considering the patient category
(majority older than 50 years and/or metastatic disease) the relative dose will
be 22/5 = 4.4 mSv which is an acceptable dose according to the ICRP 62 [9].
Furthermore, study participation may give direct benefit to the individual
patient, because it might prevent an unnecessary biopsy or surgical procedure.
The risk associated with a false-negative PET/CT is low, since lesions that
cannot be visualized with PET, i.e. do not express CAIX, are mostly benign or
low grade tumors, like chromophobic RCC. Furthermore the window of opportunity
to treat patients with RCC is wide and patients will remain under close
follow-up. Therefore this study is justified.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
His or her clinician should face a diagnostic dilemma;
- 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.
*
Age over 18 years;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.
Known hypersensitivity or HACA against Girentuximab.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54190.091.15 |