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

NCT07771621 | Enrolling By Invitation Phase 1 FDA Drug

• 2 other identifiers: FSA-Cardiac AmyloidosisDepartment funding
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Cardiac Amyloidosis

Keywords

Cardiac Amyloidosis; Light chain Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Cardiac Uptake of [18F]Fluselenamyl

  Quantitative myocardial uptake of \[18F\]Fluselenamyl measured on PET images using standardized uptake values (SUVs) and/or target-to-background ratios to evaluate cardiac amyloid deposition.

  Through study completion, an average of 2 years

Study Arms (1)

Cardiac Amyloidosis

EXPERIMENTAL

Adults with known or suspected cardiac amyloidosis who will undergo PET imaging with the investigational amyloid-targeting radiotracer \[18F\]Fluselenamyl (FSA) to evaluate myocardial amyloid deposition and cardiac tracer uptake.

Drug: [18F]Fluselenamyl (FSA)

Interventions

[18F]Fluselenamyl (FSA) DRUG

Participants will receive a single intravenous administration of the investigational PET radiotracer\[18F\]Fluselenamyl (FSA) followed by positron emission tomography (PET) imaging to evaluate myocardial amyloid deposition and assess the imaging characteristics of the radiotracer in cardiac amyloidosis. The study will also collect safety data, including monitoring for adverse events and clinical assessments

Cardiac Amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 18, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

US (1)