A Phase 1 interventional study of [18F]Fluselenamyl (FSA) in Cardiac Amyloidosis, sponsored by Washington University School of Medicine. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Diagnostic
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Among 58 studies in Amyloid Neuropathies, Familial with a site in United States — 23 open to participants now, 26 under way, 4 of them phase 3. Amyloid Neuropathies, Familial · United States.
Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, this one is the 20th largest by planned enrollment of the 38 interventional ones that give a count, is one of 6 that started in 2026, is one of 5 in phase 1, reaches primary completion later than 19 of the 25 other live ones, and was the 57th registered.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
Browse Amyloid Neuropathies, Familial studies →23 of the 58 studies in Amyloid Neuropathies, Familial with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Eidos Therapeutics, a BridgeBio company · Sites in United States
Ages 18–80
Mayo Clinic · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 30–80
University of Minnesota · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 69 Amyloid Neuropathies, Familial studies recruiting now, 53 (77%) set no upper age limit and 1 (1%) stops at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 17 · Phase 4 6
First in 2006; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Median enrollment 53 across the 38 interventional studies, 125 across the 20 observational. Of the 29 that completed or were terminated, 17 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 58 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,805 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 1 study filed under Amyloid Neuropathies, Familial — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyloid Neuropathies, Familial with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05619302Phase 3Brigham and Women's HospitalMolecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis | 2026-12-31 |
| NCT07560306Phase 3Brigham and Women's Hospital[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy | 2027-03-30 |
| NCT07196839University of Texas Southwestern Medical CenterDetermining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study | 2026-12 |
| NCT07583823University of MinnesotaElevated Rate Pacing of Cardiac Amyloidosis | 2026-12-04 |
| NCT07062848Yale UniversityAn Observational Study Using Artificial Intelligence (AI) Algorithms on Electrocardiography (ECG), Point-of-care Ultrasound (POCUS), and Transthoracic Echocardiophy (TTE) to Estimate the Under-diagnosis of Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Across a Diverse Range of US Health Systems. | 2027-01 |
Add all 11 to your calendar (.ics) → With an account.
Among the 58 studies in Amyloid Neuropathies, Familial with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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 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.
Time frame: Through study completion, an average of 2 years
Started Jan 2026 (actual). Primary completion is estimated for Dec 2029, 47 months after the start.
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Amyloid Neuropathies, Familial →
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