Recruiting
Phase 3

[64Cu]FBP8

Sponsor:

Brigham and Women's Hospital

Code:

NCT07560306

Conditions

Cardiac Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[64Cu]FBP8 PET/MR

Study Details

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

Study ID

NCT07560306

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

Interventions

[64Cu]FBP8 PET/MR

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

Primary outcome measure

  • Intracardiac Thrombus [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Vicente Morales Oyarvide, MD, MPH

6172335860vmorales-oyarvide@bwh.harvard.edu

Sharmila Dorbala, MD, MPH

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

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Vicente Morales Oyarvide, MD, MPH

6172335860vmorales-oyarvide@bwh.harvard.edu

Sharmila Dorbala, MD, MPH

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

Principal Investigator:

Sharmila Dorbala, MD, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Amyloidosis
  • Cardiac
  • Heart
  • Imaging
  • Diagnosis
  • Thrombosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-21.