Comparison of Two Contrast Agents in the Evaluation of Kidney and Adrenal Findings in MRI
Résumé de l'étude
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 étudiée
In this study, the contrast agent Gadopiclenol is investigated in the evaluation of incidental findings in the kidneys and adrenal glands using MRI.
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Inselspital Bern
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
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)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
16.06.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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