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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL109448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
The primary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Active Comparator | 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. |
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| Atrial Fibrillation Patients | Experimental | 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. |
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| COVID-19 Patients | Experimental | Thirty (30) COVID-19 patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body. |
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| Cancer Patients | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [64Cu]FBP8 | Drug | Injection of Copper-64 radiopeptide to detect thrombosis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For Atrial Fibrillation Patient subjects:
For COVID-19 Patient subjects:
For Cancer Patient subjects:
• Patient is diagnosed with cancer;
For Other Patient subjects:
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Additional exclusion criteria for Atrial Fibrillation Patient subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David E Sosnovik, MD | Contact | 617-724-3407 | sosnovik@nmr.mgh.harvard.edu | |
| Anne L Philip, MPH | Contact | 617-726-0431 | alphilip@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ciprian Catana, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34656469 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000086382 | COVID-19 |
| D009369 | Neoplasms |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Thirty (30) cancer patients will be injected with [64Cu]FBP8 and imaged for thrombi in the body.
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| Other Thrombotic Condition Patients | Experimental | Fifty (50) patients with other thrombotic conditions will be injected with [64Cu]FBP8 and imaged for thrombi in the body. |
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| PET/MR | Device | Whole body imaging using Siemens mMR PET/MR scanner |
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| Blood Collection | Procedure | A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry |
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| Electrocardiogram | Procedure | A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |