Positron Emission Tomography (PET) Imaging of Thrombosis
NCT ID: NCT03830320
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
165 participants
INTERVENTIONAL
2016-04-01
2026-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Healthy Volunteers
Twenty (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.
[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Electrocardiogram
A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
Atrial Fibrillation Patients
Thirty-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.
[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
COVID-19 Patients
Thirty (30) COVID-19 patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Cancer Patients
Thirty (30) cancer patients will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Other Thrombotic Condition Patients
Fifty (50) patients with other thrombotic conditions will be injected with \[64Cu\]FBP8 and imaged for thrombi in the body.
[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Interventions
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[64Cu]FBP8
Injection of Copper-64 radiopeptide to detect thrombosis
PET/MR
Whole body imaging using Siemens mMR PET/MR scanner
Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Electrocardiogram
A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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;
* History of syncope within the last 6 weeks;
* Heart rate persistently \>120 bpm or persistently \< 50 bpm;
* Presence of daytime pauses \> 3s
18 Years
85 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Peter Caravan
Professor of Radiology
Principal Investigators
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Ciprian Catana, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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David E Sosnovik, MD
Role: primary
References
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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.
Other Identifiers
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2015P002385
Identifier Type: -
Identifier Source: org_study_id