ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI (ELUDYN)

This study aims to understand how the volumes and speeds of intravenous injection of a recent type of contrast agent can be optimized in order to improve the information provided by medical images. To do this, five MRI scans lasting approximately 30 minutes will be performed on 10 healthy volunteers over a period of approximately 10 months. The images will then be analyzed by three radiologists who will view the images in different orders, without knowing which injection parameters were used. They will decide, based on their impressions but also on precise measurements in the images, which parameters produce the best images.

Study Overview

• Status: Active, not recruiting
• Conditions: MRI Image Enhancement; Medical Imaging Data; Contrast Agent
• Intervention / Treatment: Drug: contrast agent, Gadolinium

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Fribourg
    • Fribourg, Canton of Fribourg, Switzerland, 1700
      • HFR Hôpital Fribourgeois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ≥18 and ≤ 40 years of age at time of Informed Consent
• Informed Consent as documented by signature
• No known chronic conditions (defined by ICD-10 codes)
• Non-smoking
• French speaking

Exclusion Criteria:

• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Contraindications to the class of drug (gadopiclenol and gadoteric acid) under study, e.g. known hypersensitivity or allergy
• Claustrophobia and contraindication for MRI according to institutional practices
• Prior MRI examination with contrast agent and washout period of ≤ 2 weeks
• Prior liver, spleen, pancreatic or bowel surgery
• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Participation in another study with investigational medicinal product within the 30 days preceding and during the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection protocol 1: gadopiclenol 2 mL/s	Drug: contrast agent, Gadolinium; Each participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams.
Experimental: Injection protocol 2: gadopiclenol 1 mL/s	Drug: contrast agent, Gadolinium; Each participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams.
Experimental: Injection protocol 3: gadopiclenol 0.5 mL/s	Drug: contrast agent, Gadolinium; Each participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams.
Experimental: Injection protocol 4: gadopiclenol half dose	Drug: contrast agent, Gadolinium; Each participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams.
Active Comparator: Injection protocol 5: gadoteric acid 1 mL/s	Drug: contrast agent, Gadolinium; Each participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative evaluation of MRI images	The qualitative evaluation of the MRI images, as assessed by the median composite score of three five-items Likert scales (0 = non-diagnostic or unacceptable; 1 = poor; 2 = fair; 3 = good; 4 = excellent) across the rating of three experienced radiologists. The three Likert scales concern i) the border delineation of the vessel measured using slopes perpendicular to the vessel walls, ii) the internal homogeneity in the vessel, and iii) the visual degree of contrast enhancement. The composite score thus ranges from 0 to 12 for each reader and then the middle score (i.e., the median) between all three readers is taken for increased reliability.	October 2026

Collaborators and Investigators

• Sponsor: Hôpital Fribourgeois

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmacologic Actions; Chemical Actions and Uses; Inorganic Chemicals; Elements; Metals; Specialty Uses of Chemicals; Lanthanoid Series Elements; Metals, Rare Earth; Diagnostic Uses of Chemicals; Contrast Media; Gadolinium
• Other Study ID Numbers: 2025-01760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No