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

NCT07040865 | Recruiting Phase 4

• 1 other identifier: BASEC 2025-00253
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Suspect Renal and Adrenal Imaging Findings

Outcome Measures

Primary Outcomes (1)

• Enhancement of the kidney and adrenal tissue

  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.

  60s and 15min after contrast injection during the one and only imaging session

Study Arms (2)

Gadobutrol (control)

ACTIVE COMPARATOR

0.1 mmol/kg gadobutrol will be injected intravenously.

Drug: Gadobutrol (Gadovist/Gadavist)

Gadopiclenol

EXPERIMENTAL

0.05 mmol/kg gadopiclenol will be injected intravenously.

Drug: Gadopiclenol

Interventions

Gadobutrol (Gadovist/Gadavist) DRUG

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

Gadobutrol (control)

Gadopiclenol DRUG

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

Gadopiclenol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Interventions

gadobutrol; gadopiclenol

Study Officials

• Andreas Christe, Prof. Dr. med.

  Bern University Hospital, Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grazia M. Cereghetti, PhD

CONTACT

+41 31 632 65 80; graziamaria.cereghetti@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 27, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The Study Protocol will be made available at end of study. The availability will be open-ended.
• Access Criteria: The IPD will be available to researchers, healthcare and patients through a yet to identify platform.

Locations

CH (1)