Synergy of photoacoustic and fluorescence flow cytometry of circulating cells with negative and positive contrasts.
Dmitry A Nedosekin, Mustafa Sarimollaoglu, Ekaterina I Galanzha...
https://pubmed.ncbi.nlm.nih.gov/22903924/Actively Recruiting
Led by University of Arkansas · Updated on 2026-02-19
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating the use of a new device called Photoacoustic Flow Cytometry PAFC to detect circulating blood clots in patients with thromboembolic disease or those at high risk for such conditions. Current standard methods have limited sensitivity, especially when clot numbers in the blood are low, so this study aims to test whether PAFC can improve detection and potentially reduce complications from undetected clots. Participants will undergo the PAFC procedure, which is a novel imaging technique designed to identify clots in the bloodstream. The study does not involve comparison with other treatments but focuses on assessing the feasibility and safety of this device. The research includes monitoring for any skin sensitivity or changes related to the PAFC method over a 30-day period. During the study, patients will be evaluated through PAFC scans and blood tests measuring D-dimer levels, which are markers of clot presence. Researchers will compare clot detection results between PAFC and D-dimer tests and monitor any skin reactions. The trial involves a 30-day follow-up to assess safety and the relationship between PAFC signals and actual circulating clots. Participants will be closely observed but will continue to receive their usual care.
CONDITIONS
In Vivo Detection of Circulating Clots in Patients With Thromboembolism
S
Sanjeeva Onteddu, MD
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University of Arkansas
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational PAFC device | Current diagnostic pathway |
|---|---|---|
| What it is | Photoacoustic Flow Cytometry (PAFC) is a noninvasive diagnostic device that uses photoacoustic signals to detect circulating blood clots in vivo. | The current pathway involves diagnosis by clinical assessment, radiographic imaging, and laboratory testing such as D-dimer blood tests. |
| Role in trial | PAFC is being evaluated as a new diagnostic method for real-time detection of circulating clots in patients already diagnosed with thromboembolism. | Established diagnostic methods are used for initial diagnosis and ongoing management but are not experimental in this trial. |
| Primary use | Early detection and real-time monitoring of circulating blood clots in patients with thromboembolism. | Diagnosis of thromboembolic disease and assessment of clot presence, size, or risk through clinical evaluation, imaging (e.g., ultrasound, CT scan), or laboratory tests (e.g., D-dimer). |
| How it is given or performed | Participants undergo noninvasive PAFC procedure, in which a focused photoacoustic probe is used to detect clots within deep vessels in real time. | Diagnosis is established by clinical assessment, radiological imaging (e.g., Doppler ultrasound, CT), and blood laboratory tests (including D-dimer assays). |
| Evidence status | PAFC is investigational for clinical clot detection. Prior preclinical and human studies support potential for real-time, label-free detection, but broad clinical accuracy and impact are still under investigation. | Current diagnostic methods for thromboembolism are established, widely used, and supported by extensive literature confirming clinical accuracy and patient outcomes. |
| Important limitations | PAFC accuracy, usability, and safety (including skin sensitivity) are still under investigation. Limited clinical validation and potential for false-positive or false-negative results remain key limitations. | Clinical, radiographic, and laboratory methods may miss small or transient clots, require repetitive testing, or be affected by non-thromboembolic causes (e.g., elevated D-dimer in other conditions). |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo the Photoacoustic Flow Cytometry (PAFC) procedure to detect circulating blood clots.
1 procedure visit
Duration - Up to 30 days
Participants are monitored for safety and outcomes related to the PAFC procedure including skin sensitivity and skin property changes.
Follow-up assessments during the 30-day period
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/30460154/Ekaterina I Galanzha, Mustafa Sarimollaoglu, Dmitry A Nedosekin...
https://pubmed.ncbi.nlm.nih.gov/21976458/Mary Cushman
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https://pubmed.ncbi.nlm.nih.gov/22749928/F A Anderson, H B Wheeler, R J Goldberg...
https://pubmed.ncbi.nlm.nih.gov/2025141/Mazen A Juratli, Yulian A Menyaev, Mustafa Sarimollaoglu...
https://pubmed.ncbi.nlm.nih.gov/27227413/University of Arkansas
Lead Sponsor