Suspect Renal and Adrenal Imaging Findings
Conditions
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
Interventions
Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadobutrol contrast injection.
DRUGGadopiclenol
Magnetic resonance acquisition without contrast agent followed the same acquisition 60 s and 15 min after gadopiclenol contrast injection.
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Contacts
Primary ContactGrazia M. Cereghetti, PhD
Outcome results
None listed