ClinicalTrials.gov record NCT07560306
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
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 is a Phase 3 pilot diagnostic study testing a fibrin‑binding PET tracer ([64Cu]FBP8) paired with simultaneous cardiac PET/MRI. It enrolls people with transthyretin (ATTR-CM) or light‑chain (AL-CM) cardiac amyloidosis who have atrial fibrillation or atrial flutter. The imaging results will be compared with transesophageal echocardiogram (TEE) in twenty participants.
What it is studying. Whether [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in people with cardiac amyloidosis and atrial fibrillation/flutter, using TEE as the reference standard. The study will also explore links between thrombi, left atrial function, and left ventricular amyloid burden.
What the researchers hope to learn. To measure how well [64Cu]FBP8 PET/MRI detects intracardiac thrombi (primary goal includes testing a hypothesis of >90% detection among confirmed thrombus cases) and to examine associations with left atrial function and left ventricular amyloid burden.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The primary goal of this pilot study is to determine whether [64Cu]FBP8, a novel fibrin-binding positron emission tomography (PET) probe, can identify intracardiac thrombi when paired with simultaneous hybrid cardiac PET/MRI in twenty (20) individuals with transthyretin or light chain cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AF). The primary hypothesis of this study is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on transesophageal echocardiogram (TEE). In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- [64Cu]FBP8 PET/MR
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Have the ability to give written informed consent;
- History of amyloid cardiomyopathy (ATTR-CM or AL-CM);
- History of AF or AFL;
- Retrospective enrollment: TEE to evaluate LAA within the previous 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anticoagulation regimen, then it is unlikely that a new thrombus will develop in the LAA within the next 14 days. Likewise, if a patient not taking any anticoagulation has a thrombus in the LAA, then it is unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient remains off anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET/MR imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;
- Prospective: TEE to evaluate LAA thrombus scheduled in upcoming 14 days;
Exclusion criteria
- Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator;
- Pregnancy or breastfeeding (a negative quantitative serum or urine hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
- Claustrophobia;
- Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
- Unable to lie comfortably on a bed inside the PET/MR scanner;
- Subjects under direct or indirect (i.e., same department as PIs) supervision of the principal investigator;
- Body weight over the weight limit for the moving table (> 300 lbs for the MR table);
- Metallic or electric implants contraindicated for PET/MR scanning;
- Stroke, myocardial infarction, cardiac or major surgery within the last 3 months;
- History of LAA ligation/exclusion or presence of a LAA occlusion device;
- History of syncope within the last 6 weeks;
- Heart rate persistently >120 bpm or persistently <50 bpm;
- Daytime pauses >3 seconds;
- Lack of a prior transthoracic echocardiogram within the previous 6 months;
- Does not have the ability to give written informed consent;
- Determined by the investigator(s) to be clinically unsuitable for the study (e.g., based on screening visit and/or during study procedures);
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
[64Cu]FBP8 is a novel copper-64 labeled molecular imaging probe that selectively binds to fibrin, the main constituent of human thrombi. In animal models, [64Cu]FBP8 has been shown to effectively detect pulmonary emboli, deep venous thromboses, and intracardiac thrombi. In a first-in-human study, [64Cu]FBP8 paired with simultaneous cardiac positron emission tomography (PET) and magnetic resonance imaging (MRI) accurately detected intracardiac thrombi (specifically, left atrial appendage [LAA] thrombi) in patients with atrial fibrillation (AF) with an accuracy of >90% using transesophageal echocardiogram (TEE) as the reference standard. The investigators propose to study the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in patients with cardiac amyloidosis. This pilot study is designed to assess the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in twenty (20) patients with cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AFL) compared to TEE. The primary hypothesis is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on TEE. In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
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 will have a transesophageal echocardiogram (TEE) within the study timing rules and a single cardiac PET/MR scan after an injection of the investigational imaging agent [64Cu]FBP8. Women of child‑bearing potential will need a negative pregnancy test before the scan. The PET/MR requires lying still inside the scanner and passing MR safety checks (weight limit, no incompatible implants, tolerating enclosed spaces). Study staff will review recent transthoracic echocardiogram reports and perform screening assessments to confirm eligibility.
How the study is structured. Interventional diagnostic study. Single-group, unmasked design in which all participants receive an injection of [64Cu]FBP8 followed by simultaneous cardiac PET/MRI. Imaging findings will be compared to a transesophageal echocardiogram. Planned enrollment is twenty participants; the record lists Phase 3.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
- 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 site under ATTRv amyloidosis.
Important dates
- Study start
- Jul 7, 2026
- Primary completion
- Mar 30, 2027 (estimated)
- Study completion
- Mar 30, 2027 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Jul 21, 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
- Brigham and Women's Hospital
- Principal investigator
- Sharmila Dorbala, Director of Nuclear Cardiology
Brigham and Women's Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Vicente Morales Oyarvide, MD, MPH 📞 6172335860 ✉ vmorales-oyarvide@bwh.harvard.edu
- Sharmila Dorbala, MD, MPH 📞 617-732-6290 ✉ sdorbala@bwh.harvard.edu
Participating sites (1)
- Brigham and Women's HospitalRecruiting
Boston, Massachusetts, 02115 · United States
- Vicente Morales Oyarvide, MD, MPH · 6172335860 · vmorales-oyarvide@bwh.harvard.edu
- Sharmila Dorbala, MD, MPH · 617-732-6290 · sdorbala@bwh.harvard.edu
- Sharmila Dorbala, MD, MPH
- Vicente Morales Oyarvide, MD, MPH
- Ciprian Catana, MD
Terms used on this page · explanations by MedicalUpdates.ai
- 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.
- transesophageal echocardiogram
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- 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.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- principal investigator
- The doctor or scientist responsible for running the study at a site or overall.
- contraindicated
- 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.
- screening visit
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- 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.
- first-in-human
- The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
- magnetic resonance imaging
- 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.
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 site; 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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