Optoacoustic Detection of Inflammation Using MSOT Device

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a single arm, 3-cohort study that is designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology or radiology. The device will be used to obtain images of the areas of inflammation in the above patients for investigational use only, to compare to clinical pathology and patient's medical record. Patients will go through standard care procedures prior to imaging. Medically established diagnostic procedures will be used to detect areas of inflammation associated with GVHD, Crohn's, or colitis. Images using the MSOT device will be obtained through intact skin. A second MSOT scan will be performed for all patients 4 weeks post treatment. The temperature of the patient's skin will also be measured prior to and after MSOT imaging. MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.

Official Title
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Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography

Conditions
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Graft Vs Host Disease, Colitis, Crohn Disease

Intervention / Treatment
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* Device: MSOT Device
* Procedure: Temperature Measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients documented clinical/pathologic 1) acute or chronic colon or skin GVHD, 2) Crohn's disease, or 3) colitis Have acceptable hematologic status [total hemoglobin (tHb) ≥ 7.0 mg/dL] Patients ≥ 18 yrs of age Willing to comply with study procedures and be available for the duration of the study Patient has ability to understand and the willingness to provide a signed and dated IRB-approved informed consent document. Exclusion Criteria: Patients with a tattoo over the area of inflammation Pregnant patients are not eligible for this trial. Eligible patients (if applicable) will be required to document the date of the first day of their last menstrual cycle, and provide a negative pregnancy test if sexually active and of childbearing potential Patients who are breastfeeding Any open wound (skin ulcerations or infections) at or near the site of imaging that would preclude MSOT imaging. Any febrile illness that precludes or delays participation preoperatively

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging of Inflammatory region<br>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. | Device: MSOT Device<br>* The MSOT Device will be used to take images of the areas of inflammation in patients with inflammatory diseases such as GVHD, Colitis, and IBD, prior to, and after 4 weeks of treatment.<br>Procedure: Temperature Measurement<br>* The temperature of the skin will be measured prior to and after each instance of MSOT imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events due to MSOT imaging post enrollment. | Proportion of patients that experience adverse events as characterized by CTCAE v5.0 resulting from MSOT imaging. The first MSOT image will be taken post-enrollment on the study. The MSOT image will take up to 5 minutes and adverse events at the time of the image (1-5 minutes) and for up to 48 hours post the image will be reported. | 5 minutes for an MSOT image (up to 48 hours post-image) | 
| Adverse Events due to MSOT imaging 4 weeks after treatment. | Proportion of patients that experience adverse events as characterized by CTCAE v5.0 resulting from MSOT imaging.A second MSOT image will be taken after 4 weeks of treatment.The MSOT image will take up to 5 minutes and adverse events at the time of the image (1-5 minutes) and for up to 48 hours post the image will be reported. | 5 minutes for an MSOT image (up to 48 hours post-image) | 
| Measurement of skin temperature before first MSOT image post enrollment. | Proportion of patients with skin temperatures measured pre-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed after patient enrollment on the study. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained. | 1-2 minutes before the MSOT image. | 
| Measurement of skin temperature after first MSOT image post enrollment. | Proportion of patients with skin temperatures measured post- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed after patient enrollment on the study. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained. | 1-2 minutes after the MSOT image. | 
| Measurement of skin temperature before second MSOT image post-treatment. | Proportion of patients with skin temperatures measured pre- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed 4 weeks after treatment for the inflammatory disease. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained. | 1-2 minutes before the MSOT image. | 
| Measurement of skin temperature after second MSOT image post-treatment. | Proportion of patients with skin temperatures measured post- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed 4 weeks after treatment for the inflammatory disease. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained. | 1-2 minutes after the MSOT image. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of MSOT images to Clinical Pathology Reports for Clinical Grading of Graft Versus Host Disease. | Compare clinical grading (positivity/negativity; 1-4) and pathologic severity of skin and GI GVHD with extent of disease defined by clinical grading, and compare to oxy- and deoxy-hemoglobin values using MSOT localization. | 6 months | 
| Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease. | Compare clinical grading (positivity/negativity) of Crohn's disease with severity of Crohn's, and extent of disease defined by clinical grading and compare to oxy- and deoxy-hemoglobin values using MSOT localization. | 6 months | 
| Comparison of MSOT images to Clinical Pathology Reports for severity of colitis. | Compare clinical grading (positivity/negativity) of colitis with severity and extent of disease defined by clinical grading, and compare to oxy- and deoxy-hemoglobin values using MSOT localization. | 6 months | 
| Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports | Compare mean/median collagen deposition values obtained from MSOT across GVHD grade/response. | 6 months | 
| Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports | Compare mean/median collagen deposition values obtained from MSOT across Crohn's grade/response. | 6 months | 
| Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports | Compare mean/median collagen deposition values obtained from MSOT across colitis grade/response. | 6 months | 
| Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis. | Compare mean/median oxy- and deoxy-hemoglobin values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected at diagnosis in patients with acute or chronic GVHD. | 6 months | 
| Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis. | Compare mean/median collagen deposition values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected at diagnosis in patients with acute or chronic GVHD. | 6 months | 
| Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment. | Compare mean/median oxy- and deoxy-hemoglobin obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected 4 weeks after treatment in patients with acute or chronic GVHD. | 6 months | 
| Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment. | Compare mean/median collagen deposition values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected 4 weeks after treatment in patients with acute or chronic GVHD. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging device, inflammatory diseases