MSOT Imaging for Inflammation

(OU-SCC-O-FLAME Trial)

Recruiting at 1 trial location

Overseen By Lead Clinical Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Tattoo, Pregnant, Breastfeeding, Open wound, Febrile illness

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect inflammation in patients with chronic graft versus host disease of the skin or GI tract, Crohn's disease, or Colitis disease.

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

The trial information does not specify whether 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 MSOT Device treatment for inflammation?

The research suggests that advanced imaging techniques, like those used in the MSOT Device, can improve the detection and monitoring of inflammation, which is crucial for effective treatment planning. These imaging methods can potentially identify inflammation early and assess the response to therapy, which is beneficial for managing inflammatory diseases. ^{1 2 3 4 5}

Is MSOT Imaging safe for humans?

Optical imaging, including optoacoustic imaging like MSOT, is generally considered safe as it is noninvasive and does not use ionizing radiation. It has been successfully used in preclinical research and pilot clinical applications in humans. ^{1 6 7 8 9}

How does MSOT imaging differ from other treatments for inflammation?

MSOT imaging is unique because it is a noninvasive technique that uses light and sound to create detailed images of inflammation in the body, allowing for real-time monitoring without the need for contrast agents or invasive procedures. ^{10 11 12 13 14}

Research Team

Lacey McNally, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

Adults with chronic skin or GI tract graft-versus-host disease, Crohn's disease, or colitis can join. They must have a minimum hemoglobin level of 7.0 mg/dL and be willing to follow the study rules for its duration. Pregnant or breastfeeding individuals, those with tattoos over the inflammation site, febrile illnesses, or open wounds near the imaging area cannot participate.

Inclusion Criteria

I am willing and able to follow the study rules and attend all appointments.

I can understand and am willing to sign the consent form.

I have been diagnosed with GVHD, Crohn's disease, or colitis.

Exclusion Criteria

I do not have open wounds near the imaging area.

I do not have a fever or illness that would delay surgery.

Patients who are breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

MSOT imaging is performed to obtain images of inflammation areas for investigational use

1 day

1 visit (in-person)

Treatment

Standard care procedures are followed prior to imaging; MSOT imaging is performed before and after 4 weeks of treatment

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for adverse events and skin temperature changes post-MSOT imaging

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• MSOT Device

Trial Overview The trial is testing an experimental imaging tool called multispectral optoacoustic tomography (MSOT) to see if it can safely detect inflammation in patients with certain inflammatory conditions like graft-versus-host disease and Crohn's disease.

Participant Groups

Group I: Imaging of Inflammatory region Experimental Treatment 2 Interventions

Inflammatory regions of patients scheduled for standard of care clinical visits will be imaged using the MSOT device before and after 4 weeks of treatment. The temperature of their skin prior to and after MSOT imaging will also be measured.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

A workshop by the U.S. National Institutes of Health highlighted the need for advanced imaging techniques to effectively monitor inflammation in patients, which is crucial for guiding treatment and understanding disease progression.

Integrating new imaging methods with existing biomarkers of inflammation can enhance the clinical utility of these techniques, with the potential for significant advancements in the next 5-10 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging inflammation and its resolution in health and disease: current status, clinical needs, challenges, and opportunities. Liu, CH., Abrams, ND., Carrick, DM., et al.[2022]

Current methods for evaluating inflammation in the musculoskeletal system primarily rely on MRI and ultrasound, which assess non-specific extracellular components, but emerging cellular and molecular imaging techniques are shifting the focus to more targeted and specific evaluations of inflammation.

These advanced imaging modalities, such as PET and SPECT, could allow for earlier detection of inflammation, better quantification through biomarkers, and improved monitoring of therapeutic responses at the molecular and cellular levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging evaluation of inflammation in the musculoskeletal system: current concepts and perspectives. Bierry, G., Dietemann, JL.[2021]

Recent advancements in imaging technologies, such as improved contrast agents, allow for the visualization of inflammation in addition to traditional anatomical information, enhancing diagnostic accuracy for inflammatory diseases.

Molecular imaging of inflammatory biomarkers enables earlier diagnosis and better monitoring of diseases, which can help prevent irreversible damage and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Imaging of Inflammatory Disease. Jones, MA., MacCuaig, WM., Frickenstein, AN., et al.[2023]

Imaging inflammation in living organisms can enhance our understanding of diseases like cancer, atherosclerosis, and neurodegeneration by revealing how the immune system contributes to these conditions.

The long-term goal is to develop noninvasive imaging techniques that can serve as biomarkers for inflammation, aiding in disease diagnosis, prognosis, and monitoring treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Imaging of Inflammation: Current Status. Hammoud, DA.[2020]

A new clinical test using a radioimaging agent can quickly predict how well patients with autoimmune/inflammatory diseases will respond to various therapies by measuring uptake in inflammatory macrophages.

In animal models of diseases like rheumatoid arthritis and inflammatory bowel disease, successful treatments showed a significant decrease in the radioimaging agent uptake, indicating effectiveness long before clinical symptoms improved, which could help avoid ineffective treatments and reduce costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of Response to Therapy for Autoimmune/Inflammatory Diseases Using an Activated Macrophage-Targeted Radioimaging Agent. Kelderhouse, LE., Robins, MT., Rosenbalm, KE., et al.[2015]

In a study involving 14 rabbits, 93% developed steroid-associated osteonecrosis (ON) after receiving a low-dose lipopolysaccharide (LPS) injection followed by high-dose methylprednisolone (MPS), indicating a high incidence of ON under this experimental protocol.

The study revealed significant changes in blood parameters and imaging results, such as increased intravascular thrombus and larger extravascular marrow fat cells in ON rabbits, suggesting that both intra- and extravascular factors contribute to the development of steroid-associated ON.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multiple bioimaging modalities in evaluation of an experimental osteonecrosis model induced by a combination of lipopolysaccharide and methylprednisolone]. Qin, L., Zhang, G., Sheng, H., et al.[2016]

Optical imaging techniques, such as optoacoustic imaging, provide a noninvasive and detailed way to visualize inflammation in real-time, which is crucial for early disease detection and targeted treatment.

These advanced imaging methods can offer molecular insights into inflammatory diseases and cancers, surpassing traditional imaging techniques that only provide indirect measures of inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo optical molecular imaging of inflammation and immunity. Liu, N., Chen, X., Kimm, MA., et al.[2022]

Optical molecular imaging of inflammation is a promising new technique that can help guide medical interventions and diagnostics by identifying unique signatures of the body's inflammatory response.

The review highlights recent advancements in molecular probes targeting key immune cells, specifically neutrophils and macrophages, which play crucial roles in inflammation and disease adaptation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Molecular Imaging of Inflammatory Cells in Interventional Medicine-An Emerging Strategy. Birch, GP., Campbell, T., Bradley, M., et al.[2020]

Molecular imaging techniques are advancing our understanding of inflammation by allowing researchers to visualize and track the inflammatory process in real-time, which is crucial for disease monitoring and drug development.

This review highlights various imaging modalities, such as optical, radionuclide, and magnetic resonance imaging, that can provide insights into the stages of inflammation, from its initiation to resolution, potentially leading to new therapeutic targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging inflammation: molecular strategies to visualize key components of the inflammatory cascade, from initiation to resolution. Dorward, DA., Lucas, CD., Rossi, AG., et al.[2023]

Multispectral optoacoustic tomography (MSOT) effectively detects intestinal inflammation in a mouse model of colitis, showing significant increases in vascularity and oxygenated hemoglobin levels associated with the disease.

MSOT's findings were validated through colonoscopy and histology, suggesting it could be a promising noninvasive imaging tool for monitoring inflammatory bowel disease in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Imaging of Colitis Using Multispectral Optoacoustic Tomography. Bhutiani, N., Grizzle, WE., Galandiuk, S., et al.[2018]

Multispectral optoacoustic tomography (MSOT) is a promising imaging technique that can produce high-contrast, high-resolution images at depths of up to 5 cm, which could enhance medical diagnostics.

For MSOT to be effectively used in clinical settings, it needs improvements in probe design and data acquisition systems, as well as more user-friendly real-time visualization tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. MacCuaig, WM., Jones, MA., Abeyakoon, O., et al.[2023]

Multispectral optoacoustic tomography (MSOT) is a groundbreaking imaging technique that enables noninvasive, real-time visualization of deep tissues, providing high-resolution images without the need for contrast agents.

Recent advancements have allowed a handheld MSOT system to successfully image brown fat tissue and its metabolic activity in both mice and humans, enhancing our understanding of its role in metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multispectral Optoacoustic Tomography of Brown Adipose Tissue. Karlas, A., Reber, J., Liapis, E., et al.[2019]

A study involving 87 participants (34 with PsA, 17 with RA, and 36 healthy controls) used multispectral opto-acoustic tomography (MSOT) to identify metabolic differences between arthritis and enthesitis, revealing that arthritis is linked to increased hemoglobin levels and reduced oxygen saturation and collagen content.

In contrast, enthesitis-related changes showed increased total hemoglobin, oxygen saturation, and collagen content, indicating that MSOT can effectively differentiate between these two conditions non-invasively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive metabolic profiling of inflammation in joints and entheses by multispectral optoacoustic tomography. Tascilar, K., Fagni, F., Kleyer, A., et al.[2023]

Multispectral optoacoustic tomography (MSOT) successfully visualized blood vessels as small as 100 µm deep within 1 cm of tissue in 10 healthy volunteers, demonstrating its potential for detailed vascular imaging.

The handheld MSOT device not only identified major blood vessels but also provided information on hemoglobin oxygen saturation and arterial pulsation, indicating its efficacy for clinical assessments of vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optoacoustic Imaging of Human Vasculature: Feasibility by Using a Handheld Probe. Taruttis, A., Timmermans, AC., Wouters, PC., et al.[2018]

References

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

Imaging inflammation and its resolution in health and disease: current status, clinical needs, challenges, and opportunities. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Imaging evaluation of inflammation in the musculoskeletal system: current concepts and perspectives. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Molecular Imaging of Inflammatory Disease. [2023]

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

Molecular Imaging of Inflammation: Current Status. [2020]

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

Prediction of Response to Therapy for Autoimmune/Inflammatory Diseases Using an Activated Macrophage-Targeted Radioimaging Agent. [2015]

6. China pubmed.ncbi.nlm.nih.gov

[Multiple bioimaging modalities in evaluation of an experimental osteonecrosis model induced by a combination of lipopolysaccharide and methylprednisolone]. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

In vivo optical molecular imaging of inflammation and immunity. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Molecular Imaging of Inflammatory Cells in Interventional Medicine-An Emerging Strategy. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Imaging inflammation: molecular strategies to visualize key components of the inflammatory cascade, from initiation to resolution. [2023]

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

Noninvasive Imaging of Colitis Using Multispectral Optoacoustic Tomography. [2018]

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

Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Multispectral Optoacoustic Tomography of Brown Adipose Tissue. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Non-invasive metabolic profiling of inflammation in joints and entheses by multispectral optoacoustic tomography. [2023]

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

Optoacoustic Imaging of Human Vasculature: Feasibility by Using a Handheld Probe. [2018]