NCT05333978

Optoacoustic Detection of Inflammation Using MSOT Device

Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Vs Host Disease
• Colitis
• Crohn Disease

Interventions

Type	Name	Description
DEVICE	MSOT Device	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.
PROCEDURE	Temperature Measurement	The temperature of the skin will be measured prior to and after each instance of MSOT imaging.

Timeline

• Start date: 2022-05-31
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2022-04-19
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study