Imaging thrombosis using a new radiotracer

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

This study is testing a new imaging tool to see if it can safely and accurately help detect blood clots in patients with conditions like atrial fibrillation, COVID-19, and cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03830320 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a new radiotracer, 64Cu-FBP8, for PET-MR imaging to detect thrombosis in various conditions, including atrial fibrillation, COVID-19, and cancer. The primary goals include assessing the tracer's distribution, metabolism, and accuracy in identifying left atrial thrombosis in patients with atrial fibrillation. Additionally, the study aims to explore its feasibility for detecting thrombosis in patients with COVID-19 and cancer, as well as in those with suspected thrombus outside the left atrial appendage. The approach offers a non-invasive alternative to current standard imaging methods.

Who should consider this trial

Good fit: Ideal candidates include patients with a history of atrial fibrillation or paroxysmal atrial fibrillation who have undergone a transesophageal echocardiogram (TEE) within the last 14 days.

Not a fit: Patients without a history of atrial fibrillation or those who have not undergone recent TEE evaluations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method for accurately detecting thrombosis, improving patient outcomes and treatment strategies.

How similar studies have performed: Other studies have shown promise in using PET imaging for thrombosis detection, but the specific use of 64Cu-FBP8 is novel and untested.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Ciprian Catana, PhD — Massachusetts General Hospital
• Study coordinator: David E Sosnovik, MD

Conditions Atrial Fibrillation; COVID-19; Cancer; Thrombosis; PET-MRI