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

NCT ID: NCT07346131

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-07
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Injection protocol 1: gadopiclenol 2 mL/s

Group Type: EXPERIMENTAL

contrast agent, Gadolinium

Intervention Type: 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 2: gadopiclenol 1 mL/s

Group Type: EXPERIMENTAL

contrast agent, Gadolinium

Intervention Type: 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 3: gadopiclenol 0.5 mL/s

Group Type: EXPERIMENTAL

contrast agent, Gadolinium

Intervention Type: 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 4: gadopiclenol half dose

Group Type: EXPERIMENTAL

contrast agent, Gadolinium

Intervention Type: 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 5: gadoteric acid 1 mL/s

Group Type: ACTIVE_COMPARATOR

contrast agent, Gadolinium

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital Fribourgeois

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HFR Hôpital fribourgeois

Fribourg, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Lucien Widmer

Role: CONTACT

lucien.widmer@h-fr.ch

+41 26 306 17 73

Sandrine Foucras, Study nurse

Role: CONTACT

+41 26 306 21 06

Facility Contacts

Sandrine Foucras, Study nurse

Role: primary

sandrine.foucras@h-fr.ch

+41 26 306 21 06

Other Identifiers

2025-01760

Identifier Type: -

Identifier Source: org_study_id