Comparing gadopiclenol and gadobutrol for MRI of incidental kidney and adrenal findings
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
This test will see if the newer MRI contrast agent gadopiclenol works as well as the standard gadobutrol for adults needing MRI follow-up of incidental kidney or adrenal findings.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT07040865 on ClinicalTrials.gov |
What this trial studies
Adults with incidental renal or adrenal imaging findings who meet eligibility are randomly assigned to receive either gadopiclenol or the standard gadobutrol before a single MRI visit. Participants are informed of their assignment and undergo approximately a 60-minute MRI scan to compare image quality and diagnostic performance between the two agents. The trial is conducted at the University Hospital Bern and follows phase 4 procedures to collect practical diagnostic and safety data. Outcomes will focus on whether gadopiclenol provides equivalent diagnostic images and on any differences in tolerability.
Who should consider this trial
Good fit: Adults aged 18 or older who can undergo MRI, have an incidental kidney or adrenal finding requiring workup, have BMI under 31 kg/m2, are not pregnant or breastfeeding, and can give informed consent are ideal candidates.
Not a fit: People with MRI-incompatible implants, claustrophobia, cognitive impairment or language barriers, pregnant or breastfeeding patients, or those who do not meet the BMI or consent requirements are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, patients could have an alternative contrast option that provides equally clear MRI images and may offer advantages in dosing or safety.
How similar studies have performed: Prior clinical work with gadopiclenol and comparisons to gadobutrol in other body regions has shown promising, often comparable image quality, but data specifically for incidental renal and adrenal findings are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Department of Diagnostic, Interventional and Pediatric Radiology Inselspital, University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Andreas Christe, Prof. Dr. med. — Bern University Hospital, Inselspital
- Study coordinator: Grazia M. Cereghetti, PhD
- Email: graziamaria.cereghetti@insel.ch
- Phone: +41 31 632 65 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.