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Atrial FibrillationPhase 1NCT03830320

Positron Emission Tomography (PET) Imaging of Thrombosis

A Phase 1 study testing [64Cu]FBP8, PET/MR and Blood Collection in people with Atrial Fibrillation and COVID-19, run by Massachusetts General 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 purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation, COVID-19, Cancer
What is being tested?
[64Cu]FBP8, PET/MR and Blood Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteUnited States
Study dates
1 Apr 2016to 31 Jan 2027
Phase
Phase 1
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 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

For Atrial Fibrillation Patient subjects:

  • History of atrial fibrillation or paroxysmal atrial fibrillation;
  • Retrospective enrollment: TEE to evaluate LAA within the last 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 anti-coagulation regimen he/she is on, then it is extremely unlikely that a new thrombus will develop in the left atrial appendage within the next two weeks. Likewise, if a patient not taking any anti-coagulation has a thrombus in the left atrial appendage, then it is extremely unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient continues not to take any 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 imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;
  • Prospective enrollment: TEE to evaluate LAA scheduled in upcoming 14 days;

For COVID-19 Patient subjects:

  • Positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper or lower respiratory tract analyzed by a certified lab with an FDA approved assay within the last month;
  • Patient not requiring mechanical ventilation;

For Cancer Patient subjects:

  • Patient is diagnosed with cancer;

For Other Patient subjects:

  • Ultrasound- or CT-confirmed or high likelihood of thrombus (e.g., elevated D-dimer)
  • Has not received thrombolytics

Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Subjects less than 18 years of age;
  • Electrical implants such as cardiac pacemaker or perfusion pump;
  • Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
  • Claustrophobic reactions;
  • 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 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 MRI table and >441 lbs for the CT table);
  • Metallic or electric implants contraindicated for MR-PET scanning when applicable;
  • 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);

Additional exclusion criteria for Atrial Fibrillation Patient subjects:

  • Stroke within the last 3 months;
  • Myocardial infarction within the last 3 months;
  • Cardiac or major surgery within the last 3 months;
  • History of chest pain within the last 6 weeks unless followed by a subsequent stress test or coronary angiography;
  • History of syncope within the last 6 weeks;
  • Heart rate persistently >120 bpm or persistently < 50 bpm;
  • Presence of daytime pauses > 3s

Trial locations and contacts

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

David E Sosnovik, MD contact

617-724-3407

sosnovik@nmr.mgh.harvard.edu

Anne L Philip, MPH contact

617-726-0431

alphilip@mgh.harvard.edu

United States1 site, 1 recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    David E Sosnovik, MD

    Recruiting

Other trials in United States

About this study

Official title: Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis

The purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.

Read the detailed description

The primary objectives of this study are:

  1. To evaluate the safety of [64Cu]FBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
  2. To establish the accuracy of [64Cu]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.
  3. To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with COVID-19.
  4. To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with cancer.
  5. To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with known or suspicion of thrombus outside of the left atrial appendage.
Being tested
[64Cu]FBP8, PET/MR, Blood Collection, Electrocardiogram
Keywords
PET-MRI
Medical subject headings
Atrial Fibrillation, COVID-19, Neoplasms, Thrombosis

What participants receive

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

  • [64Cu]FBP8Drug

    Also called 64Cu-FBP8

    Injection of Copper-64 radiopeptide to detect thrombosis

  • PET/MRDevice

    Also called PET-MR

    Whole body imaging using Siemens mMR PET/MR scanner

  • Blood CollectionProcedure or surgery

    A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry

  • ElectrocardiogramProcedure or surgery

    Also called ECG

    A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer

Study groups in NCT03830320
Study groupRoleWhat they receive
Healthy VolunteersActive comparatorTwenty (20) healthy adult subjects will be injected with [64Cu]FBP8 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR. Healthy subjects will undergo blood collection before, during, and after the scan. Healthy subjects will also undergo electrocardiogram before and after the scan. An interim review of the data will be conducted after the first six subjects receive the study agent and complete all safety assessments.
Receives: Drug: [64Cu]FBP8; Device: PET/MR; Procedure: Blood Collection; Procedure: Electrocardiogram
Atrial Fibrillation PatientsExperimentalThirty-five (35) patients with LAA thrombus documented by TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus with MR-PET. The TEE studies in these patients will be part of their routine clinical care. Thirty-five (35) patients with atrial fibrillation and negative TEE will be injected with [64Cu]FBP8 and imaged for LAA thrombus. Forty (40) patients with atrial fibrillation who are scheduled for TEE in the upcoming 14 days will be injected with [64Cu]FBP8 and imaged for LAA thrombus.
Receives: Drug: [64Cu]FBP8; Device: PET/MR
COVID-19 PatientsExperimentalThirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Receives: Drug: [64Cu]FBP8; Device: PET/MR
Cancer PatientsExperimentalThirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Receives: Drug: [64Cu]FBP8; Device: PET/MR
Other Thrombotic Condition PatientsExperimentalFifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Receives: Drug: [64Cu]FBP8; Device: PET/MR

What is being measured

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

  1. Complete blood count

    To model pharmacokinetics of [64Cu]FBP8 metabolism in healthy volunteers.

    Measured: 36 hours

  2. Target to Background Ratio LAA

    To determine the signal threshold of [64Cu]FBP8 that produces the highest accuracy of [64Cu]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.

    Measured: 4 hours

  3. Target to Background Ratio

    To determine the signal threshold of [64Cu]FBP8 that produces the highest accuracy of [64Cu]FBP8 -PET to detect thrombosis in patients with known thrombus or suspicion of thrombus.

    Measured: 4 hours

  4. Time activity curve

    To evaluate human dosimetry and radiation burden in healthy volunteers.

    Measured: 48 hours

Timeline

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

  1. First posted5 Feb 2019
  2. Study start1 Apr 2016
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 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 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03830320
Sponsor's protocol ID
2015P002385
Other IDs
R01HL109448
Status last verified
Feb 2026
First submitted
28 Jan 2019
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [64Cu]FBP8, PET/MR and Blood Collection in people with Atrial Fibrillation and COVID-19, run by Massachusetts General 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?

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 27 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 David E Sosnovik, MD (617-724-3407, sosnovik@nmr.mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete blood count (time frame: 36 hours). The study lists 4 primary outcomes in all. 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 NCT03830320, which also lists 1 linked publication.

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 27 Feb 2026.

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