MSOT Imaging for Inflammation
(OU-SCC-O-FLAME Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byLacey McNally, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Disqualifiers: Tattoo, Pregnant, Breastfeeding, Open wound, Febrile illness
No Placebo Group
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.
12345Is 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.
16789How 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.
1011121314Eligibility 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 am 18 years old or older.
I can understand and am willing to sign the consent form.
+2 more
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
+2 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Imaging of Inflammatory regionExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
OU Health Stephenson Cancer CenterOklahoma City, OK
University of Oklahoma Health Sciences Center, Stephenson Cancer CenterOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
References
Imaging inflammation and its resolution in health and disease: current status, clinical needs, challenges, and opportunities. [2022]Inflammation is a normal process in our body; acute inflammation acts to suppress infections and support wound healing. Chronic inflammation likely leads to a wide range of diseases, including cancer. Tools to locate and monitor inflammation are critical for developing effective interventions to arrest inflammation and promote its resolution. To identify current clinical needs, challenges, and opportunities in advancing imaging-based evaluations of inflammatory status in patients, the U.S. National Institutes of Health convened a workshop on imaging inflammation and its resolution in health and disease. Clinical speakers described their needs for image-based capabilities that could help determine the extent of inflammatory conditions in patients to guide treatment planning and undertake necessary interventions. The imaging speakers showcased the state-of-the-art in vivo imaging techniques for detecting inflammation in different disease areas. Many imaging capabilities developed for 1 organ or disease can be adapted for other diseases and organs, whereas some have promise for clinical utility within the next 5-10 yr. Several speakers demonstrated that multimodal imaging measurements integrated with serum-based measures could improve in robustness for clinical utility. All speakers agreed that multiple inflammatory measures should be acquired longitudinally to comprehend the dynamics of unresolved inflammation that leads to disease development. They also agreed that the best strategies for accelerating clinical translation of imaging inflammation capabilities are through integration between new imaging techniques and biofluid-based biomarkers of inflammation as well as already established imaging measurements.-Liu, C. H., Abrams, N. D., Carrick, D. M., Chander, P., Dwyer, J., Hamlet, M. R. J., Kindzelski, A. L., PrabhuDas, M., Tsai, S.-Y. A., Vedamony, M. M., Wang, C., Tandon, P. Imaging inflammation and its resolution in health and disease: current status, clinical needs, challenges, and opportunities.
Imaging evaluation of inflammation in the musculoskeletal system: current concepts and perspectives. [2021]Inflammation is the non-specific stereotyped reaction of the musculoskeletal system to various types of aggression, such as infection, tumor, autoimmune diseases, or trauma. Precise evaluation and, increasingly, reliable quantification of inflammation are now key factors for optimal patient management, as targeted therapies (e.g., anti-angiogenesis, anti-macrophages, anti-cytokines) are emerging as everyday drugs. In current practice, inflammation is evaluated mostly using MRI and US on the basis of its non-specific extracellular component due to the increased volume of free water. Inflamed tissue is described as areas of low T1 signal and high T2 signal on magnetic resonance imaging or as hypoechogenic areas on ultrasound imaging, and the evaluation of the increased tissue vascularity can be performed using gadolinium-enhanced MRI or power Doppler US. Emerging new imaging tools, regrouped under the label "cellular and molecular imaging" and defined as the in vivo characterization and measurement of biologic processes at the cellular and molecular level, demonstrate the possible shift of medical imaging from a macroscopic and non-specific level to a microscopic and targeted scale. Cellular and molecular imaging now allows the investigation of specific pathways involved in inflammation (e.g., angiogenesis, cell proliferation, and recruitment, proteases generation, metabolism, gene expression). PET and SPECT imaging are the most commonly used "molecular" imaging modalities, but recent progress in MR, US, and optical imaging has been made. In the future, those techniques might enable a detection of inflammation at its very early stage, its quantification through the definition of biomarkers, and possibly demonstrate the response to therapy at molecular and cellular levels.
Molecular Imaging of Inflammatory Disease. [2023]Inflammatory diseases include a wide variety of highly prevalent conditions with high mortality rates in severe cases ranging from cardiovascular disease, to rheumatoid arthritis, to chronic obstructive pulmonary disease, to graft vs. host disease, to a number of gastrointestinal disorders. Many diseases that are not considered inflammatory per se are associated with varying levels of inflammation. Imaging of the immune system and inflammatory response is of interest as it can give insight into disease progression and severity. Clinical imaging technologies such as computed tomography (CT) and magnetic resonance imaging (MRI) are traditionally limited to the visualization of anatomical information; then, the presence or absence of an inflammatory state must be inferred from the structural abnormalities. Improvement in available contrast agents has made it possible to obtain functional information as well as anatomical. In vivo imaging of inflammation ultimately facilitates an improved accuracy of diagnostics and monitoring of patients to allow for better patient care. Highly specific molecular imaging of inflammatory biomarkers allows for earlier diagnosis to prevent irreversible damage. Advancements in imaging instruments, targeted tracers, and contrast agents represent a rapidly growing area of preclinical research with the hopes of quick translation to the clinic.
Molecular Imaging of Inflammation: Current Status. [2020]The ability to image inflammation in vivo can improve our understanding of the pathophysiology underlying various disease etiologies, including cancer, atherosclerosis, and neurodegeneration. A great wealth of preclinical and translational research has been and is currently being developed to decipher the involvement of the immune system in disease pathophysiology, quantify the course of a disease, and visualize the potential detrimental effects of excessive inflammation. Down the road, the ultimate goal is to have clinical noninvasive in vivo imaging biomarkers of inflammation that will help diagnose disease, establish prognosis, and gauge response to preventative and therapeutic strategies.
Prediction of Response to Therapy for Autoimmune/Inflammatory Diseases Using an Activated Macrophage-Targeted Radioimaging Agent. [2015]The ability to select patients who will respond to therapy is especially acute for autoimmune/inflammatory diseases, where the costs of therapies can be high and the progressive damage associated with ineffective treatments can be irreversible. In this article we describe a clinical test that will rapidly predict the response of patients with an autoimmune/inflammatory disease to many commonly employed therapies. This test involves quantitative assessment of uptake of a folate receptor-targeted radioimaging agent ((99m)Tc-EC20) by a subset of inflammatory macrophages that accumulate at sites of inflammation. Murine models of four representative inflammatory diseases (rheumatoid arthritis, inflammatory bowel disease, pulmonary fibrosis, and atherosclerosis) show markedly decreased uptake of (99m)Tc-EC20 in inflamed lesions upon initiation of successful therapies, but no decrease in uptake upon administration of ineffective therapies, in both cases long before changes in clinical symptoms can be detected. This predictive capability should reduce costs and minimize morbidities associated with failed autoimmune/inflammatory disease therapies.
[Multiple bioimaging modalities in evaluation of an experimental osteonecrosis model induced by a combination of lipopolysaccharide and methylprednisolone]. [2016]The present study employed both static and dynamic imaging modalities to study both intra- and extravascular events attributing to steroid-associated osteonecrosis (ON) using an experimental protocol with a single low-dose lippolysaccharide (LPS) injection and subsequently three injections of high-dose methylprednisolone (MPS).
In vivo optical molecular imaging of inflammation and immunity. [2022]Inflammation is the phenotypic form of various diseases. Recent development in molecular imaging provides new insights into the diagnostic and therapeutic evaluation of different inflammatory diseases as well as diseases involving inflammation such as cancer. While conventional imaging techniques used in the clinical setting provide only indirect measures of inflammation such as increased perfusion and altered endothelial permeability, optical imaging is able to report molecular information on diseased tissue and cells. Optical imaging is a quick, noninvasive, nonionizing, and easy-to-use diagnostic technology which has been successfully applied for preclinical research. Further development of optical imaging technology such as optoacoustic imaging overcomes the limitations of mere fluorescence imaging, thereby enabling pilot clinical applications in humans. By means of endogenous and exogenous contrast agents, sites of inflammation can be accurately visualized in vivo. This allows for early disease detection and specific disease characterization, enabling more rapid and targeted therapeutic interventions. In this review, we summarize currently available optical imaging techniques used to detect inflammation, including optical coherence tomography (OCT), bioluminescence, fluorescence, optoacoustics, and Raman spectroscopy. We discuss advantages and disadvantages of the different in vivo imaging applications with a special focus on targeting inflammation including immune cell tracking.
Optical Molecular Imaging of Inflammatory Cells in Interventional Medicine-An Emerging Strategy. [2020]The optical molecular imaging of inflammation is an emerging strategy for interventional medicine and diagnostics. The host's inflammatory response and adaptation to acute and chronic diseases provides unique signatures that have the potential to guide interventions. Thus, there are emerging a suite of molecular imaging and sensing approaches for a variety of targets in this area. This review will focus on two key cellular orchestrators that dominate this area, neutrophils and macrophages, with recent developments in molecular probes and approaches discussed.
Imaging inflammation: molecular strategies to visualize key components of the inflammatory cascade, from initiation to resolution. [2023]Dysregulation of inflammation is central to the pathogenesis of innumerable human diseases. Understanding and tracking the critical events in inflammation are crucial for disease monitoring and pharmacological drug discovery and development. Recent progress in molecular imaging has provided novel insights into spatial associations, molecular events and temporal sequelae in the inflammatory process. While remaining a burgeoning field in pre-clinical research, increasing application in man affords researchers the opportunity to study disease pathogenesis in humans in situ thereby revolutionizing conventional understanding of pathophysiology and potential therapeutic targets. This review provides a description of commonly used molecular imaging modalities, including optical, radionuclide and magnetic resonance imaging, and details key advances and translational opportunities in imaging inflammation from initiation to resolution.
Noninvasive Imaging of Colitis Using Multispectral Optoacoustic Tomography. [2018]Currently, several noninvasive modalities, including MRI and PET, are being investigated to identify early intestinal inflammation, longitudinally monitor disease status, or detect dysplastic changes in patients with inflammatory bowel disease. Here, we assess the applicability and utility of multispectral optoacoustic tomography (MSOT) in evaluating the presence and severity of colitis. Methods: C57B/6 mice were untreated or treated with Bacteroides fragilis and antibiotic-mediated depletion of intestinal flora to initiate colitis. Mice were imaged using MSOT to detect intestinal inflammation. Intestinal inflammation identified with MSOT was also confirmed using both colonoscopy and histology. Results: Mice with bacterial colitis demonstrated a temporally associated increase in mesenteric and colonic vascularity with an increase in mean signal intensity of oxygenated hemoglobin (P = 0.004) by MSOT 2 d after inoculation. These findings were significantly more prominent 7 d after inoculation, with increased mean signal intensity of oxygenated hemoglobin (P = 0.0002) and the development of punctate vascular lesions on the colonic surface, which corresponded to changes observed on colonoscopy as well as histology. Conclusion: With improvements in depth of tissue penetration, MSOT may hold potential as a sensitive, accurate, noninvasive imaging tool in the evaluation of patients with inflammatory bowel disease.
Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. [2023]The use of optoacoustic imaging takes advantage of the photoacoustic effect to generate high-contrast, high-resolution medical images at penetration depths of up to 5 cm. Multispectral optoacoustic tomography (MSOT) is a type of optoacoustic imaging system that has seen promising preclinical success with a recent emergence into the clinic. Multiwavelength illumination of tissue allows for the mapping of multiple chromophores, which are generated endogenously or exogenously. However, translation of MSOT to the clinic is still in its preliminary stages. For successful translation, MSOT requires refinement of probes and data-acquisition systems to tailor to the human body, along with more intuitive, real-time visualization settings. The possibilities of optoacoustic imaging, namely MSOT, in the clinic are reviewed here. ©RSNA, 2020.
Multispectral Optoacoustic Tomography of Brown Adipose Tissue. [2019]MSOT has revolutionized biomedical imaging because it allows anatomical, functional, and molecular imaging of deep tissues in vivo in an entirely noninvasive, label-free, and real-time manner. This imaging modality works by pulsing light onto tissue, triggering the production of acoustic waves, which can be collected and reconstructed to provide high-resolution images of features as deep as several centimeters below the body surface. Advances in hardware and software continue to bring MSOT closer to clinical translation. Most recently, a clinical handheld MSOT system has been used to image brown fat tissue (BAT) and its metabolic activity by directly resolving the spectral signatures of hemoglobin and lipids. This opens up new possibilities for studying BAT physiology and its role in metabolic disease without the need to inject animals or humans with contrast agents. In this chapter, we overview how MSOT works and how it has been implemented in preclinical and clinical contexts. We focus on our recent work using MSOT to image BAT in resting and activated states both in mice and humans.
Non-invasive metabolic profiling of inflammation in joints and entheses by multispectral optoacoustic tomography. [2023]To explore the metabolic characteristics of arthritis and enthesitis using multispectral opto-acoustic tomography (MSOT), a technology using near-infrared multispectral laser to stimulate tissues and detect the emitted acoustic energy, enabling non-invasive quantification of tissue components in vivo based on differential absorbance at multiple wavelengths.
Optoacoustic Imaging of Human Vasculature: Feasibility by Using a Handheld Probe. [2018]Purpose To investigate whether multispectral optoacoustic tomography (MSOT) developed for deep-tissue imaging in humans could enable the clinical assessment of major blood vessels and microvasculature. Materials and Methods The study was approved by the Institutional Review Board of the University Medical Center Groningen (CCMO-NL-43587) and registered in the Dutch National Trial Registry (NTR4125). The authors designed a real-time handheld optoacoustic scanner for human use, based on a concave 8-MHz transducer array, attaining 135° angular coverage. They applied a single-pulse-frame (SPF) sequence, which enabled motion insensitive optoacoustic imaging during handheld operation. SPF optoacoustic imaging was applied to imaging arteries and microvascular landmarks in the lower extremities of 10 healthy volunteers. The diameters selected microvessels were determined by measuring the full width at half maximum through the vessels in the MSOT images. Duplex ultrasonography was performed on the same landmarks in seven of the 10 volunteers for subjective comparison to the corresponding optoacoustic images. Results Optoacoustic imaging resolved blood vessels as small as 100 µm in diameter and within 1 cm depth. Additionally, MSOT provided images reflecting hemoglobin oxygen saturation in blood vessels, clearly identifying arteries and veins, and was able to identify pulsation in arteries during imaging. Larger blood vessels, specifically the tibialis posterior and the dorsalis pedis arteries, were also visualized with MSOT. Conclusion Handheld MSOT was found to be capable of clinical vascular imaging, providing visualization of major blood vessels and microvasculature and providing images of hemoglobin oxygen saturation and pulsation. (©) RSNA, 2016.