Clinical trial NCT05333978: Optoacoustic Detection of Inflammation Using MSOT Device
Official title: Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Vs Host Disease
Colitis
Crohn Disease
Keywords: Imaging device
inflammatory diseases
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events due to MSOT imaging post enrollment.
timeFrame: 5 minutes for an MSOT image (up to 48 hours post-image)
measure: Adverse Events due to MSOT imaging 4 weeks after treatment.
timeFrame: 5 minutes for an MSOT image (up to 48 hours post-image)
measure: Measurement of skin temperature before first MSOT image post enrollment.
timeFrame: 1-2 minutes before the MSOT image.
measure: Measurement of skin temperature after first MSOT image post enrollment.
timeFrame: 1-2 minutes after the MSOT image.
measure: Measurement of skin temperature before second MSOT image post-treatment.
timeFrame: 1-2 minutes before the MSOT image.
measure: Measurement of skin temperature after second MSOT image post-treatment.
timeFrame: 1-2 minutes after the MSOT image.
Secondary outcomes:
measure: Comparison of MSOT images to Clinical Pathology Reports for Clinical Grading of Graft Versus Host Disease.
timeFrame: 6 months
measure: Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease.
timeFrame: 6 months
measure: Comparison of MSOT images to Clinical Pathology Reports for severity of colitis.
timeFrame: 6 months
measure: Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports
timeFrame: 6 months
measure: Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports
timeFrame: 6 months
measure: Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports
timeFrame: 6 months
measure: Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
timeFrame: 6 months
measure: Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Lacey McNally, PhD
role: PRINCIPAL_INVESTIGATOR
References: