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

NCT07560306 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2025P003091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiac Amyloidosis

Keywords

Amyloidosis; Cardiac; Heart; Imaging; Diagnosis; Thrombosis

Outcome Measures

Primary Outcomes (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

  1 day

Study Arms (1)

[64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter Subjects

OTHER

Individuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo \[64Cu\]FBP8 PET/MR.

Drug: [64Cu]FBP8 PET/MR

Interventions

[64Cu]FBP8 PET/MR DRUG

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

Also known as: No other names

[64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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 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);

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 34656469 BACKGROUND

• 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.

  PMID: 35650018 BACKGROUND

• 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.

  PMID: 37227355 BACKGROUND

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Amyloidosis; Disease; Thrombosis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Vicente Morales Oyarvide, MD, MPH

CONTACT

6172335860; vmorales-oyarvide@bwh.harvard.edu

Sharmila Dorbala, MD, MPH

CONTACT

617-732-6290; sdorbala@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Cardiology

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)