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

Phase 4RecruitingNCT07040865

Insel Gruppe AG, University Hospital Bern104 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

104

Conditions

Suspect Renal and Adrenal Imaging Findings

Interventions

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

GadopiclenolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Bern, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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.

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

Central Contacts

Grazia M. Cereghetti, PhD

CONTACT

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

Data from ClinicalTrials.gov

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