Contrast Agent, Medical Imaging Data, MRI Image Enhancement
Conditions
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.
Interventions
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.
Sponsors
Hôpital Fribourgeois
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative evaluation of MRI images | 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. |
Countries
Switzerland
Outcome results
None listed