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Can a new PET tracer light up amyloid in the heart?

NCT ID NCT07771621

Diagnosis Sponsor: Washington University School of Medicine 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial is testing whether an investigational PET radiotracer called [18F]Fluselenamyl can detect amyloid deposits in the heart. Adults with confirmed or suspected cardiac amyloidosis will receive a single injection of the tracer and undergo PET imaging, along with a cardiac MRI and safety monitoring. The goal is to see if this tracer can serve as a noninvasive imaging tool to identify and characterize cardiac amyloidosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational PET radiotracer called [18F]Fluselenamyl
What this could lead to
If successful, this could lead to a noninvasive PET imaging method to detect and characterize cardiac amyloidosis, potentially improving early diagnosis and monitoring.
What could go wrong
This is an early-phase trial with a small number of participants, so the tracer's accuracy and safety are not yet established. It may not prove reliable in broader populations or outperform existing imaging methods.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

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: * Male or Female, any race * Age ≥ 18 years * Confirmed CA, clinical suspicion for CA, or markers of potential CA (i.e. left ventricular hypertrophy and heart failure) * Willing and able to undergo \[F18\]-FSA PET scan, and cardiac MRI Exclusion Criteria: * Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent * Unwilling or unable to undergo PET scan tracer injections * Participants with chronic liver diseases not related to amyloidosis * Participant has any condition that, in the investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still for the duration of the scanning procedures) * Has hypersensitivity to \[F-18\]-Fluselenamyl or any of its excipients * Contraindications to MRI (e.g. electronic medical devices that are not compatible with MRI, inability to lie still for extended periods that make it unsafe for the individual to participate) * Contraindication to contrast (gadolinium) MRI given a glomerular filtration rate (GFR) of the kidney\<30ml/min/1.7m2). In such case, only non-contrast MRI may be considered. * Severe claustrophobia * Currently pregnant or breast-feeding

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

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

Cardiac amyloidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Washington University in St. Louis

    St Louis, Missouri, 63110, United States

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