NCT03830320RecruitingPhase 1

Positron Emission Tomography (PET) Imaging of Thrombosis

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

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 165 (estimated)
First submitted: 28 Jan 2019
Start date: 1 Apr 2016
Primary completion date: 31 Jan 2027
Lead sponsor: Massachusetts General Hospital
Diseases: Atrial fibrillation
NCT number: NCT03830320

What you commit to

Study type: Interventional · Phase 1
Planned participants: 165
From 1 Apr 2016 to the primary completion date, 31 Jan 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 MR-PET scanning when applicable;

Other illness

Electrical implants such as cardiac pacemaker or perfusion pump;
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;

Lab values

Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);

Age

Subjects less than 18 years of age;

Other

Claustrophobic reactions;
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);
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:
Presence of daytime pauses \> 3s

Criteria the registry did not label

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

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Massachusetts General Hospital Coordinator of this site? Confirm its status	Boston	United States	Recruiting

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