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

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.

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Key information

Conditions

Contrast Agent MRI Image Enhancement Medical Imaging Data

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HFR Hôpital fribourgeois

Fribourg, Canton of Fribourg, 1700, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

contrast agent, Gadolinium

Drug

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.

Primary outcomes

Qualitative evaluation of MRI images

Time frame: October 2026

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.

Sponsors and collaborators

Lead sponsor

Hôpital Fribourgeois

Other

Registry information

Acronym: ELUDYN

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jan 16, 2026
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed