NCT03830320 · Massachusetts General Hospital
Positron Emission Tomography (PET) Imaging of Thrombosis
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations