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New PET scan agent could spot rare heart disease faster

NCT ID NCT06788535

Diagnosis Sponsor: Sharmila Dorbala Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging drug called I-124 evuzamitide to see if it can accurately diagnose cardiac amyloidosis, a condition where abnormal proteins build up in the heart. 204 adults with suspected cardiac amyloidosis received a single dose followed by a PET/CT scan. The goal was to check if the scan correctly identifies the disease (sensitivity) and rules it out when absent (specificity).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

204 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Understands the study procedures and can give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Male or female ≥18 years of age. * Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiogram \[ECHO\], cardiac magnetic resonance imaging \[CMR\], bone-avid tracer cardiac single-photon emission computerized tomography (SPECT), extracardiac biopsy, or endomyocardial biopsy \[EMB\]). Participants may be enrolled before or during their diagnostic evaluation for cardiac amyloidosis. * Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 30 days after administration of I-124 evuzamitide. * For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study intervention. Exclusion Criteria: * Established diagnosis of cardiac amyloidosis. * Established diagnosis of systemic amyloidosis with known organ involvement (e.g., renal AL or ATTR peripheral neuropathy). Participants who are amyloid positive only from peripheral tissue, such as abdominal fat, carpal tunnel tissue, or laminectomy tissue, are allowed as long as they do not have other known organ involvement. * Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinical trial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL and ATTR amyloidosis: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and they are enrolled in this trial, but they may not receive an experimental therapy until after the Day 30 safety follow-up visit in this trial. * Is pregnant or breast-feeding. * Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis. * Has a known allergy to KI. * Receiving hemodialysis or peritoneal dialysis. * Estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73 m\^2. * Myocardial infarction within 3 months of screening. * Has severe claustrophobia or any condition, medical or otherwise, that would prevent completion of the study assessments. * Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant. * Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to I-124 evuzamitide administration. * Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal thyroxine \[T4\]).

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac amyloidosis

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • City of Hope - Duarte

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Weston, Florida, 33331, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Cook County Health

    Chicago, Illinois, 60612, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Rutgers

    New Brunswick, New Jersey, 08901, United States

  • St. Lukes (CVIT) Saint Luke's Health System

    Kansas City, Missouri, 64111, United States

  • University of California

    San Francisco, California, 94143, United States

  • Washington University of St. Louis

    St Louis, Missouri, 63110, United States

  • Yale Cardiovascular Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.