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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

Study Summary

This trial is testing if Elucirem, a new medical imaging agent, is as effective as existing agents in detecting and visualizing lesions with abnormal vascularity.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Extracellular volume fraction (ECV)

Post-contrast T1 values

late gadolinium enhancement (LGE)

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,820,061 Total Patients Enrolled

GuerbetIndustry Sponsor

68 Previous Clinical Trials

93,712 Total Patients Enrolled

Canon Medical Systems, USAIndustry Sponsor

9 Previous Clinical Trials

784 Total Patients Enrolled

Media Library

0.05 mmol/kg Elucirem Clinical Trial Eligibility Overview. Trial Name: NCT05954559 — Phase 4

Myocardial Fibrosis Research Study Groups: 0.05 mmol/kg Elucirem, 0.075 mmol/kg Elucirem

Myocardial Fibrosis Clinical Trial 2023: 0.05 mmol/kg Elucirem Highlights & Side Effects. Trial Name: NCT05954559 — Phase 4

0.05 mmol/kg Elucirem 2023 Treatment Timeline for Medical Study. Trial Name: NCT05954559 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Elucirem been sanctioned by the FDA at a dose of 0.05 mmol/kg?

"Our Power team assigned a rating of 3 to the safety profile of 0.05 mmol/kg Elucirem, due to its Phase 4 classification which denotes official approval from regulatory bodies."

Answered by AI

Are there any spots still open for participation in this trial?

"Data hosted on clinicaltrials.gov indicates that this medical trial is not actively searching for candidates, as the last modification took place in July 13th 2023. Despite this fact, there are still 410 other trials which require participants at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment

2024. "High Relaxivity Contrast Agent for Cardiac MR in the Myocardial Scar Assessment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954559.

All > Scar