NCT03830320 Positron Emission Tomography (PET) Imaging of Thrombosis
| NCT ID | NCT03830320 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 165 participants |
| Start Date | 2016-04-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 165 participants in total. It began in 2016-04-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ciprian Catana, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT03830320 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03830320 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03830320 currently recruiting?
Yes, NCT03830320 is actively recruiting participants. Contact the research team at sosnovik@nmr.mgh.harvard.edu for enrollment information.
Where is the NCT03830320 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03830320 clinical trial?
NCT03830320 is sponsored by Massachusetts General Hospital. The principal investigator is Ciprian Catana, PhD at Massachusetts General Hospital. The trial plans to enroll 165 participants.
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