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New treatment option for Atrial Fibrillation
Official title Positron Emission Tomography (PET) Imaging of Thrombosis
ClinicalTrials.gov ID: NCT03830320
What this study is testing
What is [64Cu]FBP8?
[64Cu]FBP8 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for atrial fibrillation.
Also referred to as 64Cu-FBP8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- For Atrial Fibrillation Patient people:
- 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...
- Prospective enrollment: TEE to evaluate LAA scheduled in upcoming 14 days; For COVID-19 Patient people:
- 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...
You likely can't join if
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- people 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...
- Claustrophobic reactions;
- people will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
See the full eligibility criteria
- For Atrial Fibrillation Patient people:
- 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...
- Prospective enrollment: TEE to evaluate LAA scheduled in upcoming 14 days; For COVID-19 Patient people:
- 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 people:
- Patient is diagnosed with cancer; For Other Patient people:
- Ultrasound- or CT-confirmed or high likelihood of thrombus (e.g., elevated D-dimer)
- Has not received thrombolytics
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- people 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;
- people 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;
- people 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 people:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.