Photoacoustic Detection for Blood Clots

Overseen By Sanjeeva Onteddu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Pulmonary embolus, Acute coronary syndrome, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, Photoacoustic Flow Cytometry, which uses light and sound waves to detect blood clots in the body. It targets individuals diagnosed with blood clot-related conditions, such as deep vein thrombosis or stroke, through standard medical tests. The trial suits those diagnosed with a blood clot condition who can provide informed consent. Researchers aim to determine if the device can effectively detect blood clots in real-time. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that may lead to innovative diagnostic tools for blood clot detection.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for detecting blood clots?

Research has shown that photoacoustic flow cytometry is a promising method for quickly detecting blood clots. Studies have found that this technology can identify clots, cancer cells, and bacteria in the blood with high accuracy. Importantly, researchers have tested the safety of these devices in people, and they have been used safely to check blood oxygen levels. While the procedure is considered safe, discussing any concerns with the clinical trial team before joining is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photoacoustic Flow Cytometry (PAFC) for detecting blood clots because it offers a non-invasive and real-time monitoring option. Unlike traditional methods like ultrasound or CT scans, which can be cumbersome and time-consuming, PAFC uses laser-induced ultrasound waves to detect clots efficiently. This innovative technique allows for continuous monitoring without the need for contrast agents, making it safer for patients. The real-time detection capability could significantly improve patient outcomes by allowing for quicker interventions.

What evidence suggests that this device is effective for detecting blood clots?

Research shows that photoacoustic flow cytometry, which participants in this trial will receive, can detect blood clots in real-time with high accuracy. Studies have demonstrated that this technology finds clots in the bloodstream without needing labels or dyes, making it noninvasive and easy to use. It uses light and sound waves to identify small changes in blood flow caused by clots. Early results suggest this method effectively detects clots made of both red and white blood cells. This makes it a promising tool for diagnosing and monitoring blood clots, especially in people at risk for conditions where blood clots form in blood vessels. ^{1 2 3 6 7}

Who Is on the Research Team?

Sanjeeva Onteddu, MD

Principal Investigator

University of Arkansas

Jonathan A Young

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for adults over 18 with thromboembolic disease, confirmed by standard tests like ultrasound. It's not for those needing acute embolectomy/thrombectomy, with unstable heart conditions, intracardiac clots, pregnant/breastfeeding women, severe infections or mental illness, recent trauma patients or those on certain ventilator support.

Inclusion Criteria

I have been diagnosed with a blood clot or stroke recently.

Informed consent provided by the subject

Exclusion Criteria

I have had a clot removed through surgery or a special procedure.

I have a heart rhythm problem but it's controlled with medication.

I have had a recent heart attack or unstable chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Subjects will receive the PAFC procedure to detect circulating blood clots

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Photoacoustic Flow Cytometry

Trial Overview The study is testing the feasibility of a new device that uses Photoacoustic Flow Cytometry to detect circulating blood clots in vivo in patients who have or are at high risk for thromboembolism.

How Is the Trial Designed?

Group I: Procedure Experimental Treatment 1 Intervention

Subjects will receive PAFC procedure

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

The study introduces multispectral photoacoustic flow cytometry (PAFC) as a promising method for real-time monitoring of circulating tumor cells and bacteria using multiple dyes, demonstrating its ability to accurately measure dye concentrations in vivo.

PAFC successfully enumerated different types of blood cells and detected rare dead cells in the bloodstream, indicating its potential for clinical applications in monitoring blood volume and liver function, especially in critical medical situations like surgery and trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo multispectral photoacoustic and photothermal flow cytometry with multicolor dyes: a potential for real-time assessment of circulation, dye-cell interaction, and blood volume. Proskurnin, MA., Zhidkova, TV., Volkov, DS., et al.[2021]

A new photoacoustic flow cytometry technique allows for real-time detection of circulating cells and nanoparticles in living organisms, demonstrating high sensitivity capable of identifying one cancer cell among 10 million normal blood cells.

This method was successfully applied in vivo to study the behavior of cancer cells and nanoparticles in mouse models, with potential future applications in human medicine for cancer detection and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo photoacoustic flow cytometry for monitoring of circulating single cancer cells and contrast agents. Zharov, VP., Galanzha, EI., Shashkov, EV., et al.[2019]

The study demonstrated that photoacoustic imaging can effectively detect red blood cell aggregation, with theoretical and experimental results supporting this capability using human and porcine RBCs.

As the size of red blood cell aggregates increases, the dominant frequency of the photoacoustic signals shifts towards clinically relevant ranges, indicating that larger aggregates produce stronger signals, which could enhance diagnostic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the use of photoacoustics to detect red blood cell aggregation. Hysi, E., Saha, RK., Kolios, MC.[2021]

The study successfully demonstrated that in vivo photoacoustic flow cytometry (PAFC) can non-invasively detect and differentiate between types of emboli in real-time, marking a significant advancement in early embolus detection technology.

Increased levels of circulating emboli were observed in tumor-bearing mice compared to tumor-free mice, suggesting that cancer progression and surgical procedures can elevate embolus formation, highlighting the potential of PAFC in preventing thromboembolic complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Label-Free Embolus Detection Using In Vivo Photoacoustic Flow Cytometry. Juratli, MA., Menyaev, YA., Sarimollaoglu, M., et al.[2020]

A dual modal clinical ultrasound and photoacoustic imaging system can effectively detect fast-moving blood clots in real-time, which is crucial for early diagnosis of deep vein thrombosis (DVT).

The imaging technique showed a significantly higher signal-to-noise ratio for blood clots compared to the surrounding blood flow, making it easier to identify clots even at high velocities of up to 107 cm/sec.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Label-free high frame rate imaging of circulating blood clots using a dual modal ultrasound and photoacoustic system. Das, D., Sivasubramanian, K., Rajendran, P., et al.[2021]

A new photothermal/photoacoustic (PT/PA) imaging technique allows for the detection of negative signals, enabling the identification of different types of blood clots in real-time, which could improve early detection of thromboembolism-related conditions like strokes and heart attacks.

This method can measure the concentration and size of clots as small as 20 μm in a mouse model and human blood, suggesting its potential for monitoring cardiovascular disease risk and evaluating treatment efficacy without the need for labels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts. Galanzha, EI., Sarimollaoglu, M., Nedosekin, DA., et al.[2021]

The study demonstrates that photoacoustic flow cytometry (PAFC) can effectively detect circulating blood clots (CBCs) in larger and deeper blood vessels in rat and rabbit models, showcasing its potential for real-time diagnosis of thrombosis and embolism.

PAFC successfully identifies different types of blood clots (white, red, and mixed) using a focused ultrasound transducer and a high pulse rate laser, indicating a significant advancement over existing detection methods that are unable to perform such in vivo assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe. Juratli, MA., Menyaev, YA., Sarimollaoglu, M., et al.[2020]

In vivo photoacoustic flow cytometry (PAFC) shows promise for early, noninvasive diagnosis of various conditions, including cancer and infections, by detecting circulating cells and clots in the bloodstream.

The study introduces a new calibration method using a dynamic blood flow phantom that mimics human tissue and blood, which enhances the accuracy of PAFC in clinical settings by effectively suppressing background signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic blood flow phantom with negative and positive photoacoustic contrasts. Jawad, HJ., Sarimollaoglu, M., Biris, AS., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4799719/

Photoacoustic flow cytometry - PMC - PubMed Central - NIH This technology provides an unprecedented capability for real-time detection of tumor cells, bacteria, and clots in circulation with ultra-high sensitivity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6238938/

Noninvasive label-free detection of circulating white and red ... We confirmed that PAFC can detect both red and white CBCs induced by microsurgical procedures, such as a needle or catheter insertion, as well ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1046202312001442

Photoacoustic flow cytometry We summarize recent advances of new generation flow cytometry for in vivo noninvasive label-free or targeted detection of cells in blood, lymph, bone, cerebral ...

4. spiedigitallibrary.org spiedigitallibrary.org/journals/journal-of-biomedical-optics/volume-24/issue-12/121902/Combined-ultrasound-and-photoacoustic-imaging-of-blood-clot-during-microbubble/10.1117/1.JBO.24.12.121902.full

Combined ultrasound and photoacoustic imaging of blood ... Sonothrombolysis, is a noninvasive procedure to break down blood clots using focused ultrasound (US) waves. Sonothrombolysis is shown to have ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cyto.a.21106

In vivo flow cytometry of circulating clots using negative ... Currently, PA technique is one of the fastest growing areas of biomedical imaging which have been effective for diagnosis of malignancy, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005573/

Combined ultrasound and photoacoustic imaging of blood ... However, these blood clots are harmful when they obstruct the blood flow through healthy blood vessels. Cardiovascular diseases such as ...

7. nature.com nature.com/articles/srep21531

In vivo acoustic and photoacoustic focusing of circulating ... We introduce method for manipulation of circulating cells in vivo with the use of gradient acoustic forces induced by ultrasound and photoacoustic waves.