High Relaxivity Contrast Agent for Myocardial Fibrosis

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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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. Elucirem enhances MRI images, making it easier to see problem areas. The study aims to find the best dose for clear imaging. Elucirem is a special dye used to improve MRI scans.

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 data supports the effectiveness of the drug Elucirem (Gadopiclenol) for myocardial fibrosis?

Gadopiclenol, the active ingredient in Elucirem, has been shown to be effective in enhancing MRI images for detecting and characterizing lesions in the brain and body, with a favorable safety profile. It has been found to be as effective as other similar contrast agents in visualizing lesions, which suggests it could be useful for identifying myocardial fibrosis (heart tissue scarring) as well. ^{1 2 3 4 5}

How does the drug gadopiclenol differ from other treatments for myocardial fibrosis?

Gadopiclenol is unique because it is a high-relaxivity gadolinium-based contrast agent designed to enhance MRI imaging, which can help in better detecting and characterizing lesions. This is different from other treatments for myocardial fibrosis, which may not focus on improving imaging quality. ^{3 4 5 6 7}

Research Team

Joao Lima, Professor

Principal Investigator

MD

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Gadopiclenol and P846, 2 High-Relaxivity Macrocyclic Magnetic Resonance Contrast Agents Without Protein Binding, in a Rodent Model of Hepatic Metastases: Potential Solutions for Improved Enhancement at Ultrahigh Field Strength. [2020]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of Pharmacokinetic, Pharmacodynamic Profile, and Tolerance of Gadopiclenol, A New High Relaxivity GBCA, in Healthy Subjects and Patients With Brain Lesions (Phase I/IIa Study). [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preclinical Safety Assessment of Gadopiclenol: A High-Relaxivity Macrocyclic Gadolinium-Based MRI Contrast Agent. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Gadolinium Distribution of the New High-Relaxivity Gadolinium Chelate Gadopiclenol in a Rat Model of Severe Renal Failure. [2023]