RecruitingPhase 4NCT07040865

Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

104 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Suspect Renal and Adrenal Imaging Findings

Summary

The purpose of this study is to compare the effects of the contrast agent Gadopiclenol with those of the standard contrast agent Gadobutrol. The main question of this study is : Does gadopiclenol offer diagnostic properties that are equally effective as those of gadobutrol? Participants will be: * randomly assigned to one of two groups: the experimental group, which receives gadopiclenol, or the control group, which receives gadobutrol. Each participant is informed of their group allocation prior to the magnetic resonance imaging (MRI) scan. * invited for a single MRI appointment lasting approximately 60 minutes

Eligibility

Min Age: 18 Years

Inclusion Criteria5

signed informed consent
age ≥18 years
compatibility with magnetic resonance imaging
planned workup of kidney incidental finding or adrenal incidental findings (or both)
body mass index (BMI) < 31 kg/m2

Exclusion Criteria5

patients with implants that might affect imaging parameters in the region under investigation, as judged by the principal investigator
vulnerable individuals
claustrophobic individuals
individuals that are cognitively impaired or unable to understand the language
pregnant or breastfeeding patients

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Interventions

DRUGGadobutrol (Gadovist/Gadavist)

Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadobutrol contrast injection.

DRUGGadopiclenol

Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadopiclenol contrast injection.

Locations(1)

Department of Diagnostic, Interventional and Pediatric Radiology Inselspital, University of Bern

Bern, Switzerland

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NCT07040865