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Cardiac AmyloidosisPhase 3NCT07560306

[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy

A Phase 3 study testing [64Cu]FBP8 PET/MR in people with Cardiac Amyloidosis, run by Brigham and Women's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… 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?
[64Cu]FBP8 PET/MR
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
7 Jul 2026to 30 Mar 2027
Phase
Phase 3
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

  • 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;

Who cannot join

  • 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;
Show all 16Show fewer
  • 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);

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vicente Morales Oyarvide, MD, MPH contact

6172335860

vmorales-oyarvide@bwh.harvard.edu

Sharmila Dorbala, MD, MPH contact

617-732-6290

sdorbala@bwh.harvard.edu

United States1 site, 1 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Vicente Morales Oyarvide, MD, MPH, 6172335860, vmorales-oyarvide@bwh.harvard.edu

    Sharmila Dorbala, MD, MPH, 617-732-6290, sdorbala@bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

[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.

Being tested
[64Cu]FBP8 PET/MR
Keywords
Amyloidosis, Cardiac, Heart, Imaging, Diagnosis, Thrombosis
Medical subject headings
Amyloid Neuropathies, Familial, Amyloidosis, Disease, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [64Cu]FBP8 PET/MRDrug

    Also called No other names

    Simultaneous cardiac PET/MR images will be obtained following injection of [64Cu]FBP8.

Study groups in NCT07560306
Study groupRoleWhat they receive
[64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter SubjectsOtherIndividuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo [64Cu]FBP8 PET/MR.
Receives: Drug: [64Cu]FBP8 PET/MR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intracardiac Thrombus

    Presence or absence of intracardiac thrombus based on [64Cu]FBP8 PET/MR imaging, as determined by standardized uptake values (SUV), and transesophageal echocardiogram

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start7 Jul 2026
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Mar 2027 (estimated)

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560306
Sponsor's protocol ID
2025P003091
Status last verified
Jul 2026
First submitted
24 Apr 2026
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Izquierdo-Garcia D, Desogere P, Philip AL, Mekkaoui C, Weiner RB, Catalano OA, Iris Chen YC, DeFaria Yeh D, Mansour M, Catana C, Caravan P, Sosnovik DE. Detection and Characterization of Thrombosis in Humans Using Fibrin-Targeted Positron Emission Tomography and Magnetic Resonance. JACC Cardiovasc Imaging. 2022 Mar;15(3):504-515. doi: 10.1016/j.jcmg.2021.08.009. Epub 2021 Oct 13.

    PubMed 34656469

  • Vilches S, Fontana M, Gonzalez-Lopez E, Mitrani L, Saturi G, Renju M, Griffin JM, Caponetti A, Gnanasampanthan S, De Los Santos J, Gagliardi C, Rivas A, Dominguez F, Longhi S, Rapezzi C, Maurer MS, Gillmore J, Garcia-Pavia P. Systemic embolism in amyloid transthyretin cardiomyopathy. Eur J Heart Fail. 2022 Aug;24(8):1387-1396. doi: 10.1002/ejhf.2566. Epub 2022 Jul 11.

    PubMed 35650018

  • Donnellan E, Hussain M, Marrouche N, Park M, Martin M, Hanna M, Wazni O, Collier P, Jaber W. Left Atrial Strain May Predict Thrombus Formation in Patients With Transthyretin Cardiac Amyloidosis. JACC Clin Electrophysiol. 2023 Aug;9(8 Pt 1):1418-1420. doi: 10.1016/j.jacep.2023.03.013. Epub 2023 May 24. No abstract available.

    PubMed 37227355

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [64Cu]FBP8 PET/MR in people with Cardiac Amyloidosis, run by Brigham and Women's Hospital 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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 21 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Vicente Morales Oyarvide, MD, MPH (6172335860, vmorales-oyarvide@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracardiac Thrombus (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560306, which also lists 3 linked publications.

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 21 Jul 2026.

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