Cardiac AmyloidosisPhase 1FSA-CANCT07771621
PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis
A Phase 1 study testing [18F]Fluselenamyl (FSA) in people with Cardiac Amyloidosis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- [18F]Fluselenamyl (FSA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: [18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
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.
Read the detailed description
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
- Conditions
- Cardiac Amyloidosis
- Being tested
- [18F]Fluselenamyl (FSA)
- Keywords
- Cardiac Amyloidosis, Light chain Amyloidosis
- Medical subject headings
- Amyloid Neuropathies, Familial, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]Fluselenamyl (FSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start14 Jan 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771621
- Sponsor's protocol ID
- FSA-Cardiac Amyloidosis
- Other IDs
- Department funding
- Acronym
- FSA-CA
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
- ClinicalTrials.gov ID
- NCT07771621
- Acronym / sponsor ID
- FSA-CA / FSA-Cardiac Amyloidosis
- Conditions
- Cardiac Amyloidosis
- Keywords
- Cardiac Amyloidosis, Light chain Amyloidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Amyloidosis | Experimental | Drug: [18F]Fluselenamyl (FSA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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 | Drug | Cardiac Amyloidosis |
Primary outcome
Cardiac Uptake of [18F]Fluselenamyl
Time frame: Through study completion, an average of 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]Fluselenamyl (FSA) in people with Cardiac Amyloidosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Uptake of [18F]Fluselenamyl (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.