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

Trial Summary

What is the purpose of this trial?

Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.

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 data supports the effectiveness of the treatment Photoacoustic Flow Cytometry for detecting blood clots?

Research shows that Photoacoustic Flow Cytometry (PAFC) can effectively detect blood clots in real-time, distinguishing between different types of clots in animal models. It has been demonstrated to identify clots in both small and large blood vessels, offering potential for early diagnosis and prevention of complications like stroke and heart attack. ^{1 2 3 4 5}

Is photoacoustic detection for blood clots safe for humans?

The research on photoacoustic flow cytometry (PAFC) for detecting blood clots has been conducted in animal models, such as mice, rats, and rabbits, and shows potential for non-invasive and real-time detection of clots. While these studies highlight the technique's promise, they do not provide specific safety data for humans. ^{1 2 3 4 5}

How does the treatment Photoacoustic Flow Cytometry differ from other treatments for blood clots?

Photoacoustic Flow Cytometry is unique because it uses sound waves generated by laser light to detect blood clots in real-time without needing any dyes or labels. This noninvasive method can identify different types of clots in deep blood vessels, which is not possible with existing techniques. ^{2 4 6 7 8}

Research Team

Sanjeeva Onteddu, MD

Principal Investigator

University of Arkansas

Jonathan A Young

Principal Investigator

University of Arkansas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Label-free high frame rate imaging of circulating blood clots using a dual modal ultrasound and photoacoustic system. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts. [2021]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Real-Time Label-Free Embolus Detection Using In Vivo Photoacoustic Flow Cytometry. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

On the use of photoacoustics to detect red blood cell aggregation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

In vivo photoacoustic flow cytometry for monitoring of circulating single cancer cells and contrast agents. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Dynamic blood flow phantom with negative and positive photoacoustic contrasts. [2021]