Comparison of Two Contrast Agents in the Evaluation of Kidney and Adrenal Findings in MRI
Summary description of the study
When unclear masses are discovered in an organ during an examination, these so-called incidental findings must be further investigated. This is sometimes done with an additional, targeted examination of the affected organ. In this case, masses found in the kidneys or adrenal glands are further examined using MRI. This examination in our clinic is supported by a contrast agent containing the active ingredient Gadobutrol. In our study, we aim to quantify how effective a new contrast agent called Gadopiclenol is. We do not yet use this new contrast agent in our routine, but it is already being used in the USA and in other countries in Europe. There is already research on humans regarding this contrast agent, and previous studies on humans as well as clinical applications have shown that it is safe and effective for diagnostics. Therefore, in this study, we investigate to what extent the new contrast agent is comparable to the old one, which could not be determined from the already existing qualitative assessment.
(BASEC)
Intervention under investigation
In this study, the contrast agent Gadopiclenol is investigated in the evaluation of incidental findings in the kidneys and adrenal glands using MRI.
(BASEC)
Disease under investigation
Investigation of a new contrast agent in the evaluation of kidney and adrenal findings in MRI
(BASEC)
Patients who require an MRI evaluation of kidney or adrenal findings, are older than 17 years, and are compatible with MRI. (BASEC)
Exclusion criteria
Patients who have a contraindication for MRI, such as certain implants, or suffer from severe renal impairment, as well as pregnant and breastfeeding women will be excluded from the study. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital Bern
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Andreas Christe
+41 31 632 19 65
andreas.christe@clutterinsel.chDepartment of Diagnostic, Interventional and Pediatric Radiology Inselspital, Bern University Hospital, Bern, Switzerland Rosenbühlgasse 27 CH-3010 Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
16.06.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Randomized, single-blind, monocentric, non-inferiority trial of gadopiclenol (Vueway®) contrast agent performance vs. gadobutrol (Gadovist®) in the workup of incidental renal and adrenal findings (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
not available
Link to the results in the primary register
not available