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

Hôpital Fribourgeois

Status and phase: Enrolling; Phase 4

Conditions: Medical Imaging Data; Contrast Agent; MRI Image Enhancement

Treatments: Drug: contrast agent, Gadolinium

Study type: Interventional

Funder types: Other

Identifiers

NCT07346131

2025-01760

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 5 patient groups

Injection protocol 1: gadopiclenol 2 mL/s

Experimental group

Treatment:

Drug: contrast agent, Gadolinium

Injection protocol 2: gadopiclenol 1 mL/s

Experimental group

Treatment:

Drug: contrast agent, Gadolinium

Injection protocol 3: gadopiclenol 0.5 mL/s

Experimental group

Treatment:

Drug: contrast agent, Gadolinium

Injection protocol 4: gadopiclenol half dose

Experimental group

Treatment:

Drug: contrast agent, Gadolinium

Injection protocol 5: gadoteric acid 1 mL/s

Active Comparator group

Treatment:

Drug: contrast agent, Gadolinium