Optoacoustic Detection of Inflammation Using MSOT Device

Last updated: February 20, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammation

Inflammatory Bowel Disease

Crohn's Disease

Treatment

MSOT Device

Temperature Measurement

Clinical Study ID

NCT05333978
OU-SCC-O-FLAME
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy

  • Patient has ability to understand and the willingness to provide a signed and datedIRB-approved informed consent document.

Exclusion

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 menstrualcycle, and provide a negative pregnancy test if sexually active and of childbearingpotential

  • Patients who are breastfeeding

  • Any open wound (skin ulcerations or infections) at or near the site of imaging thatwould preclude MSOT imaging.

  • Any febrile illness that precludes or delays participation preoperatively

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: MSOT Device
Phase:
Study Start date:
May 31, 2022
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73014
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

    Oklahoma City, Oklahoma 73014
    United States

    Active - Recruiting

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