Optoacoustic Detection of Inflammation Using MSOT Device

NCT05333978 | Suspended DMC FDA Device

• 1 other identifier: OU-SCC-O-FLAME
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis; Crohn Disease; Graft Vs Host Disease

Keywords

Imaging device; inflammatory diseases

Outcome Measures

Primary Outcomes (6)

• Adverse Events due to MSOT imaging post enrollment.

  Proportion of patients that experience adverse events as characterized by CTCAE v5.0 resulting from MSOT imaging. The first MSOT image will be taken post-enrollment on the study. The MSOT image will take up to 5 minutes and adverse events at the time of the image (1-5 minutes) and for up to 48 hours post the image will be reported.

  5 minutes for an MSOT image (up to 48 hours post-image)

• Adverse Events due to MSOT imaging 4 weeks after treatment.

  Proportion of patients that experience adverse events as characterized by CTCAE v5.0 resulting from MSOT imaging.A second MSOT image will be taken after 4 weeks of treatment.The MSOT image will take up to 5 minutes and adverse events at the time of the image (1-5 minutes) and for up to 48 hours post the image will be reported.

  5 minutes for an MSOT image (up to 48 hours post-image)

• Measurement of skin temperature before first MSOT image post enrollment.

  Proportion of patients with skin temperatures measured pre-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed after patient enrollment on the study. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained.

  1-2 minutes before the MSOT image.

• Measurement of skin temperature after first MSOT image post enrollment.

  Proportion of patients with skin temperatures measured post- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed after patient enrollment on the study. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained.

  1-2 minutes after the MSOT image.

• Measurement of skin temperature before second MSOT image post-treatment.

  Proportion of patients with skin temperatures measured pre- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed 4 weeks after treatment for the inflammatory disease. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained.

  1-2 minutes before the MSOT image.

• Measurement of skin temperature after second MSOT image post-treatment.

  Proportion of patients with skin temperatures measured post- MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. MSOT imaging will be performed 4 weeks after treatment for the inflammatory disease. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained.

  1-2 minutes after the MSOT image.

Secondary Outcomes (10)

• Comparison of MSOT images to Clinical Pathology Reports for Clinical Grading of Graft Versus Host Disease.

  6 months

• Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease.

  6 months

• Comparison of MSOT images to Clinical Pathology Reports for severity of colitis.

  6 months

• Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports

  6 months

• Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports

  6 months

Study Arms (1)

Imaging of Inflammatory region

EXPERIMENTAL

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.

Device: MSOT Device; Procedure: Temperature Measurement

Interventions

MSOT Device 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.

Imaging of Inflammatory region

Temperature Measurement PROCEDURE

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

Imaging of Inflammatory region

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73014, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Colitis; Crohn Disease

Condition Hierarchy (Ancestors)

Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases

Study Officials

• Lacey McNally, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: April 19, 2022
• Study Start: May 31, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)