Positron Emission Tomography (PET) Imaging of Thrombosis

February 25, 2026 updated by: Peter Caravan, Massachusetts General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • David E Sosnovik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Healthy Volunteers
Twenty (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.
Drug: [64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
Other Names:
  • 64Cu-FBP8
Device: PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Names:
  • PET-MR
Procedure: Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Procedure: Electrocardiogram
A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
Other Names:
  • ECG
Experimental: Atrial Fibrillation Patients
Thirty-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.
Drug: [64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
Other Names:
  • 64Cu-FBP8
Device: PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Names:
  • PET-MR
Experimental: COVID-19 Patients
Thirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Drug: [64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
Other Names:
  • 64Cu-FBP8
Device: PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Names:
  • PET-MR
Experimental: Cancer Patients
Thirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Drug: [64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
Other Names:
  • 64Cu-FBP8
Device: PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Names:
  • PET-MR
Experimental: Other Thrombotic Condition Patients
Fifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
Drug: [64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
Other Names:
  • 64Cu-FBP8
Device: PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Names:
  • PET-MR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete blood count
Time Frame: 36 hours
To model pharmacokinetics of [64Cu]FBP8 metabolism in healthy volunteers.
36 hours
Target to Background Ratio LAA
Time Frame: 4 hours
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.
4 hours
Target to Background Ratio
Time Frame: 4 hours
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.
4 hours
Time activity curve
Time Frame: 48 hours
To evaluate human dosimetry and radiation burden in healthy volunteers.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ciprian Catana, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015P002385
  • R01HL109448 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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