Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07040865

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Suspect Renal and Adrenal Imaging Findings

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Andreas Christe, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Grazia M. Cereghetti, PhD

CONTACT

[email protected]

+41 31 632 65 80

Grazia M. Cereghetti, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gadobutrol (Gadovist/Gadavist)

Drug

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

Gadopiclenol

Drug

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

Primary outcomes

  1. Enhancement of the kidney and adrenal tissue

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grazia M. Cereghetti, PhD

CONTACT

[email protected]

+41 31 632 65 80

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: IRAF-WORKUP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.