Status:
RECRUITING
Optoacoustic Detection of Inflammation Using MSOT Device
Lead Sponsor:
University of Oklahoma
Conditions:
Graft Vs Host Disease
Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
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 correla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05333978
Start Date
May 31 2022
End Date
May 1 2028
Last Update
January 8 2026
Active Locations (1)
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1
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73014