Contrast AgentPhase 4ELUDYNNCT07346131
ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI
A Phase 4 study testing contrast agent, Gadolinium in people with Contrast Agent and Medical Imaging Data, run by Hôpital Fribourgeois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast Agent, Medical Imaging Data, MRI Image Enhancement
- What is being tested?
- contrast agent, Gadolinium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jan 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
HFR Hôpital fribourgeois
Fribourg, Canton of Fribourg, 1700
About this study
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
- Being tested
- contrast agent, Gadolinium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast agent, GadoliniumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Injection protocol 1: gadopiclenol 2 mL/s | Experimental | Not described Receives: Drug: contrast agent, Gadolinium |
| Injection protocol 2: gadopiclenol 1 mL/s | Experimental | Not described Receives: Drug: contrast agent, Gadolinium |
| Injection protocol 3: gadopiclenol 0.5 mL/s | Experimental | Not described Receives: Drug: contrast agent, Gadolinium |
| Injection protocol 4: gadopiclenol half dose | Experimental | Not described Receives: Drug: contrast agent, Gadolinium |
| Injection protocol 5: gadoteric acid 1 mL/s | Active comparator | Not described Receives: Drug: contrast agent, Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: October 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start7 Jan 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Fribourgeois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346131
- Sponsor's protocol ID
- 2025-01760
- Other IDs
- 2025
- Acronym
- ELUDYN
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELUDYN: Assessment of Intra-individual Variability of Vascular Dynamics of Gadopiclenol Injection Parameters in Contrast-enhanced MRI
- ClinicalTrials.gov ID
- NCT07346131
- Acronym / sponsor ID
- ELUDYN / 2025-01760
- Conditions
- Contrast Agent, Medical Imaging Data, MRI Image Enhancement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hôpital FribourgeoisUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast agent, GadoliniumEach participant undergoes five abdominal MRI exams with distinct injection protocols in a random order with at least a 2-week interval between each exams. | Drug | 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 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing contrast agent, Gadolinium in people with Contrast Agent and Medical Imaging Data, run by Hôpital Fribourgeois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative evaluation of MRI images (time frame: October 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.