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
2 other identifiers
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 atrial-fibrillation
Started Apr 2016
Longer than P75 for phase_1 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
February 27, 2026
February 1, 2026
10.8 years
January 28, 2019
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Complete blood count
To model pharmacokinetics of \[64Cu\]FBP8 metabolism in healthy volunteers.
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.
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.
4 hours
Time activity curve
To evaluate human dosimetry and radiation burden in healthy volunteers.
48 hours
Study Arms (5)
Healthy Volunteers
ACTIVE COMPARATORTwenty (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
EXPERIMENTALThirty-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
EXPERIMENTALThirty (30) COVID-19 patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
Cancer Patients
EXPERIMENTALThirty (30) cancer patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
Other Thrombotic Condition Patients
EXPERIMENTALFifty (50) patients with other thrombotic conditions will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
Interventions
A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
Injection of Copper-64 radiopeptide to detect thrombosis
Whole body imaging using Siemens mMR PET/MR scanner
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Eligibility Criteria
You may not qualify if:
- 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);
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
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.
PMID: 34656469DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ciprian Catana, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology
Study Record Dates
First Submitted
January 28, 2019
First Posted
February 5, 2019
Study Start
April 1, 2016
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02