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

NCT07346131 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2025-01760
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contrast Agent; Medical Imaging Data; MRI Image Enhancement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Injection protocol 1: gadopiclenol 2 mL/s

EXPERIMENTAL

Drug: contrast agent, Gadolinium

Injection protocol 2: gadopiclenol 1 mL/s

EXPERIMENTAL

Drug: contrast agent, Gadolinium

Injection protocol 3: gadopiclenol 0.5 mL/s

EXPERIMENTAL

Drug: contrast agent, Gadolinium

Injection protocol 4: gadopiclenol half dose

EXPERIMENTAL

Drug: contrast agent, Gadolinium

Injection protocol 5: gadoteric acid 1 mL/s

ACTIVE COMPARATOR

Drug: contrast agent, Gadolinium

Interventions

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.

Injection protocol 1: gadopiclenol 2 mL/s; Injection protocol 2: gadopiclenol 1 mL/s; Injection protocol 3: gadopiclenol 0.5 mL/s; Injection protocol 4: gadopiclenol half dose; Injection protocol 5: gadoteric acid 1 mL/s

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Fribourgeois: lead

Study Sites (1)

HFR Hôpital fribourgeois

Fribourg, Canton of Fribourg, 1700, Switzerland

Location

MeSH Terms

Interventions

Contrast Media; Gadolinium

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)