Optoacoustic Detection of Inflammation Using MSOT Device

NCT ID: NCT05333978

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2028-05-01

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.

Conditions

Graft Vs Host Disease; Colitis; Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Imaging of Inflammatory region

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.

Group Type: EXPERIMENTAL

MSOT Device

Intervention Type: 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.

Temperature Measurement

Intervention Type: PROCEDURE

The temperature of the skin will be measured prior to and after each instance of MSOT imaging.

Interventions

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.

Intervention Type: DEVICE

Temperature Measurement

The temperature of the skin will be measured prior to and after each instance of MSOT imaging.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lacey McNally, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lead Clinical Coordinator

Role: CONTACT

SCC-IIT-Office@ouhsc.edu

1-405-271-8777

Facility Contacts

Lacey McNally

Role: primary

lacey-mcnally@ouhsc.edu

405-325-0789

Other Identifiers

OU-SCC-O-FLAME

Identifier Type: -

Identifier Source: org_study_id