NCT07040865

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Suspect Renal and Adrenal Imaging Findings

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadovist/Gadavist)	Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadobutrol contrast injection.
DRUG	Gadopiclenol	Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadopiclenol contrast injection.

Timeline

• Start date: 2025-08-18
• Primary completion: 2027-06-30
• Completion: 2027-07-31
• First posted: 2025-06-27
• Last updated: 2025-11-19

Locations

1 site across 1 country: Switzerland