PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis | NCT07771621 | Trialant

Enrolling by invitationInterventionalPhase 1Updated Aug 18, 2026

PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis

[18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07771621
Lead Sponsor: Washington University School of MedicineOTHER
Overall Status: Enrolling by invitation
Study Type: Interventional
Phase: Phase 1
Enrollment: 50Estimated
Last Update Posted: Aug 18, 2026Actual
Start Date: Jan 14, 2026Actual
Primary Completion Date: Dec 2029Estimated
Completion Date: Dec 2030Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: [18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
Brief Summary: This observational study will evaluate the imaging performance of the investigational positron emission tomography (PET) radiotracer[18F]Fluselenamyl (FSA) in individuals with cardiac amyloidosis. The study aims to determine whether [18F]Fluselenamyl PET imaging can detect and characterize amyloid deposits in the heart.

Participants will undergo PET imaging following administration of [18F]Fluselenamyl, along with clinical assessments and other study procedures as needed. Imaging results will be used to assess tracer uptake in the heart and to evaluate the potential of [18F]Fluselenamyl as a noninvasive tool for detecting cardiac amyloidosis. The study will also collect safety information, including clinical assessments, laboratory testing, and monitoring for adverse events. This research may help establish [18F]Fluselenamyl as a novel imaging biomarker for cardiac amyloidosis.

Conditions

The medical conditions and diseases this study investigates.

Cardiac Amyloidosis

Interventions

The treatments and procedures being evaluated in this study.

[18F]Fluselenamyl (FSA)

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Washington University in St. Louis

St Louis, Missouri 63110, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Washington University School of MedicineOTHER

Similar Studies

Other registered studies that closely resemble this one.

Cardiac amyloidosis is a progressive disorder characterized by the deposition of misfolded amyloid proteins within the myocardium, leading to increased ventricular wall thickness, impaired cardiac function, heart failure, arrhythmias, and reduced survival. Early and accurate detection of cardiac amyloid deposits is important for diagnosis, treatment selection, and monitoring of disease progression. Current diagnostic approaches often require a combination of imaging studies, laboratory testing, and, in some cases, invasive tissue biopsy.

[18F]Fluselenamyl (FSA) is an investigational positron emission tomography (PET) radiotracer that binds to amyloid fibrils and has shown promise for imaging amyloid deposition. This study is being conducted to evaluate the imaging characteristics of [18F]Fluselenamyl in individuals with cardiac amyloidosis and to determine its potential utility as a noninvasive imaging biomarker for cardiac amyloid burden. The investigation is based on prior development and human imaging experience with [18F]Fluselenamyl as an amyloid-targeting PET radiotracer.

Participants with known or suspected cardiac amyloidosis will undergo PET imaging following intravenous administration of [18F]Fluselenamyl. Additional study procedures may include medical history review, physical examination, laboratory testing, electrocardiography, and collection of safety data before and after tracer administration. Imaging data will be analyzed to characterize tracer uptake within the myocardium and to assess the ability of [18F]Fluselenamyl PET to identify cardiac amyloid deposition. Safety assessments will include monitoring for adverse events, vital signs, clinical laboratory values, and other clinically relevant findings.

The results of this study may support the development of [18F]Fluselenamyl as a novel PET imaging agent for the noninvasive detection and evaluation of cardiac amyloidosis and may provide information that could improve diagnosis, disease characterization, and future assessment of therapeutic response