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NCT07538544 · ClinicalTrials.gov registry record · Early Phase 1

MCE Molecular Imaging for ICI Myocarditis

A Early Phase 1 study, sponsored by University of Virginia.

Not yet
Registry status
Early Phase 1
Development phase
30
Enrollment target

NCT07538544: Clinical Trial Early Phase 1 study, sponsored by University of Virginia.

NCT07538544 is a Early Phase 1 study that has not yet begun recruiting, run by University of Virginia. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07538544, a Early Phase 1 study, has not yet begun recruiting, sponsored by University of Virginia.

NOT YET RECRUITING
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target

Study Summary

Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. A new class of medications used for cancer called immune checkpoint inhibitors (ICI) work by increasing the body's inflammmation response, but can have a side effect of causing inflammation of the heart (ICI myocarditis). Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether ICI myocarditis can be diagnosed using a new form of ultrasound imaging of the heart (echocardiography) that uses a contrast agent that is targeted to inflammation (Sonazoid).

Primary Outcome

The ability of of MCE molecular imaging with Sonazoid to diagnose myocarditis will be determined by comparing to a gold standard (either cardiac MRI or myocardial biopsy).

Interventions

  • DIAGNOSTIC_TEST Myocardial contrast echocardiography molecular imaging for inflammation

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-07-01
Est. Completion 2030-07-01
Phase Early Phase 1
University of Virginia

449 total trials

What is known before NCT07538544 opens enrollment

NCT07538544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 1 intervention - of which Myocardial contrast echocardiography molecular imaging for inflammation is the first listed.

NCT07538544 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07538544 about?

NCT07538544 is a clinical study titled "MCE Molecular Imaging for ICI Myocarditis". Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. A new class of medications used for cancer called immune checkpoint inhibitors (ICI) work by increasing the body's inflammmation response, but can have a si...

What is the current status of trial NCT07538544?

This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2026-07-01. Estimated completion is 2030-07-01.

What interventions are being tested in trial NCT07538544?

The interventions under investigation include: Myocardial contrast echocardiography molecular imaging for inflammation (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT07538544?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07538544's enrollment target sits among peer trials

30 807th of 2000 higher than 1,074 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07538544, the US trial registry maintained by the National Library of Medicine. NCT07538544 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.