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.
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
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- 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.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
David E Sosnovik, MD
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:
- To evaluate the safety of [64Cu]FBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
- To establish the accuracy of [64Cu]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with COVID-19.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with cancer.
- 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.
- Conditions
- Atrial Fibrillation, COVID-19, Cancer, Thrombosis
- 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 group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | 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. Receives: Drug: [64Cu]FBP8; Device: PET/MR; Procedure: Blood Collection; Procedure: Electrocardiogram |
| Atrial Fibrillation Patients | Experimental | 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. Receives: Drug: [64Cu]FBP8; Device: PET/MR |
| COVID-19 Patients | Experimental | Thirty (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 Patients | Experimental | Thirty (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 Patients | Experimental | Fifty (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.
Complete blood count
To model pharmacokinetics of [64Cu]FBP8 metabolism in healthy volunteers.
Measured: 36 hours
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
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
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.
- First posted5 Feb 2019
- Study start1 Apr 2016
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Peter Caravan, Massachusetts General Hospital
- Investigators
- Ciprian Catana, PhD, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
- ClinicalTrials.gov ID
- NCT03830320
- Acronym / sponsor ID
- 2015P002385
- Conditions
- Atrial Fibrillation, COVID-19, Cancer, Thrombosis
- Keywords
- PET-MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objectives of this study are:
- To evaluate the safety of [64Cu]FBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
- To establish the accuracy of [64Cu]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with COVID-19.
- To explore the feasibility of [64Cu]FBP8 -PET to detect thrombosis in patients with cancer.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Drug: [64Cu]FBP8, Device: PET/MR, Procedure: Blood Collection, Procedure: ElectrocardiogramTwenty (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. |
| Atrial Fibrillation Patients | Experimental | Drug: [64Cu]FBP8, Device: PET/MRThirty-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. |
| COVID-19 Patients | Experimental | Drug: [64Cu]FBP8, Device: PET/MRThirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body. |
| Cancer Patients | Experimental | Drug: [64Cu]FBP8, Device: PET/MRThirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body. |
| Other Thrombotic Condition Patients | Experimental | Drug: [64Cu]FBP8, Device: PET/MRFifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [64Cu]FBP8Also: 64Cu-FBP8Injection of Copper-64 radiopeptide to detect thrombosis | Drug | Atrial Fibrillation Patients, COVID-19 Patients, Cancer Patients, Healthy Volunteers, Other Thrombotic Condition Patients |
| PET/MRAlso: PET-MRWhole body imaging using Siemens mMR PET/MR scanner | Device | Atrial Fibrillation Patients, COVID-19 Patients, Cancer Patients, Healthy Volunteers, Other Thrombotic Condition Patients |
| Blood CollectionA total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry | Procedure or surgery | Healthy Volunteers |
| ElectrocardiogramAlso: ECGA standard 12-lead ECG will be obtained pre-and-post injection with radiotracer | Procedure or surgery | Healthy Volunteers |
Primary outcome
Complete blood count
Time frame: 36 hours
To model pharmacokinetics of [64Cu]FBP8 metabolism in healthy volunteers.
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.
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.
Time activity curve
Time frame: 48 hours
To evaluate human dosimetry and radiation burden in healthy volunteers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 34656469Izquierdo-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ciprian Catana, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
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.