ClinicalTrials.gov record NCT07771621
PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis
[18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1 diagnostic study tests an investigational PET radiotracer, [18F]Fluselenamyl, in people with known or suspected cardiac amyloidosis. Participants receive a single intravenous dose of the tracer and undergo PET imaging; the study also collects clinical assessments, laboratory tests, ECG, cardiac MRI, and safety data. Imaging will be analyzed to measure tracer uptake in the heart.
What it is studying. The study is testing whether PET imaging after a single IV dose of [18F]Fluselenamyl can detect and characterize amyloid deposits in the heart and is assessing the tracer's imaging characteristics and safety.
What the researchers hope to learn. To evaluate the imaging characteristics of [18F]Fluselenamyl in cardiac amyloidosis; quantify myocardial tracer uptake (for example, standardized uptake values and target-to-background ratios); and collect safety information to inform development of the tracer as a noninvasive imaging biomarker for cardiac amyloid burden.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- [18F]Fluselenamyl (FSA)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive a single intravenous injection of the investigational PET radiotracer [18F]Fluselenamyl (FSA) and undergo PET imaging to measure tracer uptake in the heart. They will also have cardiac MRI (which may use gadolinium contrast unless contraindicated; non-contrast MRI may be considered if GFR <30 ml/min/1.7m2), a medical history review, a physical exam, laboratory testing, and electrocardiography. Study staff will collect safety information before and after tracer administration, including monitoring for adverse events and vital signs.
How the study is structured. Phase 1 interventional diagnostic study with a single treatment group and no masking. Each participant receives one intravenous administration of the investigational PET radiotracer [18F]Fluselenamyl and has PET imaging of the heart. The study also includes medical history and physical exam, laboratory testing, electrocardiography (ECG), cardiac MRI, and monitoring for adverse events, vital signs, and clinical laboratory values.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says participants are enrolled by invitation. Who decides who is invited, and how?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this website under AL amyloidosis and ATTRv amyloidosis.
Important dates
- Study start
- Jan 14, 2026
- Primary completion
- December 2029 (estimated)
- Study completion
- December 2030 (estimated)
- Target enrollment
- 50 participants (estimated)
- Last updated on registry
- Aug 18, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Washington University School of Medicine
Participating sites (1)
- Washington University in St. Louis
St Louis, Missouri, 63110 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- observational study
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- positron emission tomography
- A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- biomarker
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- legally authorized representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- Contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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