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NCT07560306RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
20 (estimated)
First submitted
24 Apr 2026
Start date
7 Jul 2026
Primary completion date
30 Mar 2027
Lead sponsor
Brigham and Women's Hospital
Diseases
Amyloidosis
NCT number
NCT07560306

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 20
  • From 7 Jul 2026 to the primary completion date, 30 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
  • Metallic or electric implants contraindicated for PET/MR scanning;
  • Lack of a prior transthoracic echocardiogram within the previous 6 months;

Other illness

  • Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator;
  • 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;

Lab values

  • 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);

Other

  • Claustrophobia;
  • 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);
  • Daytime pauses \>3 seconds;
  • 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);

Who the study is looking for

  • 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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.