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

Not Applicable

Not yet recruiting

• Conditions: Suspect Renal and Adrenal Imaging Findings
• Interventions: Drug: Gadobutrol (Gadovist/Gadavist); Drug: Gadopiclenol

• Registration Number: NCT07040865
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gadobutrol (control)	Gadobutrol (Gadovist/Gadavist)	0.1 mmol/kg gadobutrol will be injected intravenously.
Gadopiclenol	Gadopiclenol	0.05 mmol/kg gadopiclenol will be injected intravenously.

Primary Outcome Measures

Name	Time	Method
Enhancement of the kidney and adrenal tissue	60s and 15min after contrast injection during the one and only imaging session	The primary endpoint is the enhancement of the kidney and adrenal tissue (difference of T1, longitudinal relaxation time, of the organ signal before and after contrast agent application) in both contrast agent groups 60s and 15min after contrast injection.

Trial Locations

Locations (1)

Department of Diagnostic, Interventional and Pediatric Radiology Inselspital, University of Bern; 🇨🇭 Bern, Switzerland