Optoacoustic Detection of Inflammation Using MSOT Device (OU-SCC-O-FLAME)

University of Oklahoma (OU)

Status: Suspended

Conditions: Graft Vs Host Disease; Colitis; Crohn Disease

Treatments: Device: MSOT Device; Procedure: Temperature Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05333978

OU-SCC-O-FLAME

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Imaging of Inflammatory region

Experimental group

Description:

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.

Treatment:

Procedure: Temperature Measurement

Device: MSOT Device