High Relaxivity Contrast Agent for Myocardial Fibrosis

Recruiting at 1 trial location

Overseen By Joao Lima, Professor

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Disqualifiers: Kidney disease, Metal fragments, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new contrast agent called Elucirem (Gadopiclenol), used in MRI scans to better highlight heart muscle scars. Researchers aim to determine if a lower dose of Elucirem is as effective as a higher dose of another contrast agent, Dotarem. The study includes individuals who participated in a previous MRI study with Dotarem. Ideal participants are those without claustrophobia, with healthy kidney function, and without metal implants or electronic devices in the body. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What is the safety track record for Elucirem (Gadopiclenol)?

Research has shown that Elucirem (Gadopiclenol) is generally safe and well-tolerated. The FDA approved it in 2022 for use in MRI scans after testing confirmed its safety and effectiveness. In the first year after approval, safety data indicated that the benefits of Elucirem outweigh the risks. However, some individuals might experience allergic reactions, and those with certain kidney problems could be at risk. Overall, Elucirem has demonstrated a positive safety record based on its use to date. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Elucirem because it offers a new approach to detecting myocardial fibrosis. Unlike existing contrast agents, Elucirem uses gadopiclenol, a high relaxivity agent that provides clearer and more detailed images of the heart tissue. This allows for more accurate diagnosis and assessment of fibrosis, potentially leading to better treatment decisions. With two different doses being studied, Elucirem could tailor imaging to individual patient needs, offering flexibility and precision in cardiac care.

What evidence suggests that Elucirem could be effective for myocardial fibrosis?

Research has shown that Elucirem, a type of contrast dye, is approved and effective for MRI scans to detect lesions in various body parts. Studies have demonstrated that Elucirem provides much clearer images than traditional contrast dyes. It enhances MRI images at least twice as effectively, making them clearer even at lower doses. One study found that even at half the usual dose, Elucirem was as effective as other full-dose dyes in body MRI scans. This trial will evaluate two different doses of Elucirem, 0.05 mmol/kg and 0.075 mmol/kg, to assess its effectiveness in detecting heart tissue damage in heart MRI scans. ^{6 7 8 9 10}

Who Is on the Research Team?

Joao Lima, Professor

Principal Investigator

MD

Are You a Good Fit for This Trial?

This trial is for adults over 21 years old who have previously participated in a cardiac MR study with Dotarem, are not claustrophobic, weigh under 120kg, and have normal kidney function (eGFR of 60 or more). It's not for those with metal fragments in sensitive areas, pregnant women, people with internal electrical devices like pacemakers, anyone allergic to gadolinium-based contrast agents or those unable to undergo MRI due to severe conditions.

Inclusion Criteria

I was in the previous Doatrem CMR study and agree to join this one.

I am over 21, weigh less than 120kg, not afraid of tight spaces, and my kidney function is normal.

Exclusion Criteria

I am younger than 21 years old.

I cannot have an MRI due to kidney issues, metal implants, pregnancy, allergies to MRI dye, or severe claustrophobia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Dose Evaluation

Evaluation of optimal dose of Elucirem (0.05 mmol/kg or 0.075 mmol/kg) by assessing myocardial T1 mapping in normal volunteers

25 minutes post-contrast

Multiple T1 mapping sessions every 2.5 minutes

Phase II Scar Assessment

Scar assessment in patients with a scar from a previous double-dose Dotarem study using the optimal dose determined in Phase I

1-2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elucirem (Gadopiclenol)

Trial Overview The trial tests if a half dose of Elucirem (0.05mmol/kg), a new high relaxivity contrast agent for MRI scans, is as effective as a double dose (0.2 mmol/kg) of the already approved agent Dotarem in assessing myocardial scars during cardiac MR imaging.

How Is the Trial Designed?

Group I: 0.075 mmol/kg Elucirem Experimental Treatment 1 Intervention

A group that receives 0.075 mmol/kg Elucirem

Group II: 0.05 mmol/kg Elucirem Experimental Treatment 1 Intervention

a group that receives 0.05 mmol/kg Elucirem

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Guerbet

Industry Sponsor

Trials

72

Recruited

94,600+

David Hale

Guerbet

Chief Executive Officer since 2020

MBA from IMD

Philippe Bourrinet

Guerbet

Chief Medical Officer since 2023

MD

Canon Medical Systems, USA

Industry Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

Gadopiclenol, a new gadolinium-based contrast agent, is effective for MRI, showing noninferior performance to gadobutrol in visualizing lesions, and it does not require dose adjustments for pediatric patients aged 2-17, as its pharmacokinetics are similar to adults.

A safety analysis involving 1047 participants revealed that gadopiclenol has a favorable safety profile, with no significant safety concerns in pediatric, elderly, or renal impairment patients, comparable to other existing contrast agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Hao, J., Pitrou, C., Bourrinet, P.[2023]

Gadopiclenol, a new gadolinium-based contrast agent, has a pharmacokinetic profile in children aged 2 to 17 years that is similar to that observed in adults, indicating no need for age-based dose adjustments.

The study demonstrated that gadopiclenol at a dose of 0.05 mmol/kg is safe, with only 2.5% of children experiencing mild adverse events, and it significantly improves lesion detection and diagnostic confidence in MRI imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. Jurkiewicz, E., Tsvetkova, S., Grinberg, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05954559

NCT05954559 | High Relaxivity Contrast Agent for Cardiac ... The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment. All ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10480682/

Review of the Efficacy and Safety of Gadopiclenol The results of this review show overall significantly improved diagnostic accuracy in comparison to conventional GBCAs and demonstrated lower ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.222612

Efficacy and Safety of Half-Dose Gadopiclenol versus Full- ... Gadopiclenol at half the standard dose for contrast-enhanced body MRI had comparable efficacy with gadobutrol at the full standard dose.

4. withpower.com withpower.com/trial/phase-4-fibrosis-8-2023-b8e3f

High Relaxivity Contrast Agent for Myocardial Fibrosis This trial tests Elucirem, a special dye for MRI scans, in adults and children aged 2+ to improve imaging of lesions with abnormal blood vessels.

5. bracco.com bracco.com/article/data-reinforcing-efficacy-and-safety-gadopiclenol-contrast-enhanced-mri-certain-body

Data Reinforcing Efficacy and Safety of Gadopiclenol in ... The results of the multicenter, international PROMISE clinical trial demonstrate that gadopiclenol provides similar lesion visualization and ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/216986s000lbl.pdf

Elucirem - accessdata.fda.gov ELUCIREM is contraindicated in patients with history of hypersensitivity reactions to ELUCIREM. 5 WARNINGS AND PRECAUTIONS. 5.1 Nephrogenic Systemic Fibrosis.

7. ema.europa.eu ema.europa.eu/en/documents/assessment-report/elucirem-epar-public-assessment-report_en.pdf

Elucirem, gadopiclenol - EMA None of the additional data would impact on the safety assessment of gadopiclenol. In the non-clinical toxicity studies, no differences ...

8. guerbet.com guerbet.com/media/x0ikwz1h/elucirem_productmonograph_us_digital-version.pdf

PRODUCT MONOGRAPH ELUCIREM™ (gadopiclenol) injection Important Safety Information. WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF). See full prescribing information for complete ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11441729/

A New Contrast Agent for MRI of the CNS and Body Based on the efficacy and safety data reported in this review, the Food and Drug Administration has granted gadopiclenol approval in 2022, and ...

10. journals.lww.com journals.lww.com/investigativeradiology/fulltext/2025/06000/safety_of_gadopiclenol_after_its_first_year_of.8.aspx

Safety of Gadopiclenol After Its First Year of Clinical Use Safety data from postmarketing surveillance of gadopiclenol further confirm its positive benefit-risk profile demonstrated in preapproval clinical studies.