Study Summary
This trial is testing a new radiotracer to see if it can detect thrombosis (clots) in the body using PET-MR imaging. This could provide a non-invasive alternative to current methods.
- Blood Clot
- Cancer
- Coronavirus
- Atrial Fibrillation
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: 48 hours
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
5 Treatment Groups
Healthy Volunteers
1 of 5
COVID-19 Patients
1 of 5
Cancer Patients
1 of 5
Atrial Fibrillation Patients
1 of 5
Other Thrombotic Condition Patients
1 of 5
Active Control
Experimental Treatment
240 Total Participants · 5 Treatment Groups
Primary Treatment: [64Cu]FBP8 · No Placebo Group · Phase 1
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 85 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Izquierdo-Garcia, David, Pauline Désogère, Anne L. Philip, Choukri Mekkaoui, Rory B. Weiner, Onofrio A. Catalano, Yin-Ching Iris Chen, et al.. 2022. “Detection and Characterization of Thrombosis in Humans Using Fibrin-targeted Positron Emission Tomography and Magnetic Resonance”. JACC: Cardiovascular Imaging. Elsevier BV. doi:10.1016/j.jcmg.2021.08.009.
- Izquierdo-Garcia, David, Pauline Désogère, Anne L. Philip, Choukri Mekkaoui, Rory B. Weiner, Onofrio A. Catalano, Yin-Ching Iris Chen, et al.. 2022. “Detection and Characterization of Thrombosis in Humans Using Fibrin-targeted Positron Emission Tomography and Magnetic Resonance”. JACC: Cardiovascular Imaging. Elsevier BV. doi:10.1016/j.jcmg.2021.08.009.
- 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.
- Peter Caravan 2016. "Positron Emission Tomography (PET) Imaging of Thrombosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03830320.
Frequently Asked Questions
Is the age criterion for this trial including individuals over 25 years old?
"This clinical trial is open to those aged 18 and over, up until the age of 85." - Anonymous Online Contributor
Has [64Cu]FBP8 received the necessary regulatory approval from the FDA?
"Our company's evaluation of [64Cu]FBP8's safety gave it a score of 1, which is the lowest on this scale. This rating reflects that there is only minimal clinical data available to assess its efficacy and safety profile." - Anonymous Online Contributor
Is my involvement in this experiment permissible?
"This clinical trial requires enrolment of 240 participants between the ages 18 and 85 with thrombus. Furthermore, certain criteria need to be met for prospective enrollment: TEE must be completed in next 14 days; SARS-CoV-2 RNA detected by RT-PCR collected from upper or lower respiratory tract analyzed within last month; patient not requiring mechanical ventilation; diagnosed with cancer; ultrasound or CT confirmed/high likelihood of thrombus (e.g., elevated D-dimer); no prior use of thrombolytics and a history of atrial fibrillation/paroxysmal atrial fibrillation" - Anonymous Online Contributor
Is there still availability for participation in this experiment?
"Affirmative. Clinicaltrials.gov's records reveal that this study, which was launched on August 1st 2016, is actively searching for volunteers to take part in the experiment. A total of 240 subjects are required from one distinct medical centre." - Anonymous Online Contributor
What is the maximum capacity of participants in this trial?
"Affirmative. The information accessible on clinicaltrials.gov states that recruitment for this investigation is ongoing. It was first posted back in August 1st 2016 and the latest update occurred February 3rd 2022, with an aim of enrolling 240 patients at a single site." - Anonymous Online Contributor