What side effects are associated with this type of intervention?

Common side effects of gadolinium-based contrast agents (GBCAs) used in myocardial fibrosis imaging include mild injection site reactions such as pain, erythema, and bruising. Serious adverse effects are rare but can include nephrogenic systemic fibrosis (NSF) in patients with severe renal impairment. The safety profile of high relaxivity agents like Elucirem (Gadopiclenol) in cardiac MRI is still being studied.

What prior FDA approvals exist?

Gadolinium-based contrast agents (GBCAs) have been widely used for enhanced MRI imaging to detect and visualize myocardial fibrosis. Prior FDA-approved GBCAs include Gadopentetate dimeglumine (Magnevist), Gadobenate dimeglumine (MultiHance), and Gadoteridol (ProHance). These agents help in the detailed visualization of myocardial tissue, aiding in the assessment of myocardial fibrosis. Elucirem (Gadopiclenol), a newer high relaxivity GBCA, was approved by the FDA in 2022 for use in adults and children aged 2 years and older, specifically for detecting lesions with abnormal vascularity in various body regions, including the myocardium.

What other types of research exist?

Promising alternatives to Elucirem (Gadopiclenol) for myocardial fibrosis patients in 2024 may include other high relaxivity gadolinium-based contrast agents such as Gadobutrol or Gadoterate meglumine, which are known for their efficacy in enhanced MRI imaging. Additionally, advancements in non-contrast imaging techniques like T1 and T2 mapping, as well as the use of novel imaging agents like manganese-based contrast agents, could provide effective alternatives for myocardial fibrosis assessment.

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High Relaxivity Contrast Agent for Myocardial Fibrosis

Phase 4

Waitlist Available

Led By Joao Lima, Professor

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for Elucirem aren't detailed here, similar contrast agents can cause reactions at the injection site, headache, nausea, dizziness or allergic reactions including rash and itching. Kidney issues may occur especially in those with pre-existing kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-inferiority of half dose of Elucirem to double dose Dotarem

Secondary study objectives

Extracellular volume fraction (ECV)

Post-contrast T1 values

late gadolinium enhancement (LGE)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 0.075 mmol/kg EluciremExperimental Treatment1 Intervention

A group that receives 0.075 mmol/kg Elucirem

Group II: 0.05 mmol/kg EluciremExperimental Treatment1 Intervention

a group that receives 0.05 mmol/kg Elucirem

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gadolinium-based contrast agents (GBCAs) like Elucirem (Gadopiclenol) are used in enhanced MRI imaging to detect and visualize myocardial scars by increasing the contrast in MRI images. The high relaxivity of Elucirem allows for superior image quality at lower doses, which is particularly important for patients with Myocardial Fibrosis. Accurate imaging helps in diagnosing the extent of fibrosis, enabling healthcare providers to tailor treatment strategies more effectively, ultimately improving patient outcomes.