Clinical trial NCT03830320: Positron Emission Tomography (PET) Imaging of Thrombosis
Official title: Preliminary Evaluation of [64Cu]FBP8 in Healthy Individuals and Subjects With Known or at Risk of Developing Thrombosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atrial Fibrillation
COVID-19
Cancer
Thrombosis
Keywords: PET-MRI
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-05
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 the current standard-of-care methods.

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.

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

Primary outcomes:
measure: Complete blood count
timeFrame: 36 hours
measure: Target to Background Ratio LAA
timeFrame: 4 hours
measure: Target to Background Ratio
timeFrame: 4 hours
measure: Time activity curve
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ciprian Catana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.