Using a new imaging device to detect inflammation in certain chronic diseases
Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography
NA · University of Oklahoma · NCT05333978
This study is testing a new imaging device to see if it can safely and effectively detect inflammation in patients with chronic graft versus host disease, Crohn's disease, or colitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05333978 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a novel imaging device called multispectral optoacoustic tomography (MSOT) for detecting inflammation in patients with chronic graft versus host disease, Crohn's disease, or colitis. It is a single-arm, three-cohort study where patients will undergo standard care procedures before imaging. The MSOT device will capture images of inflamed areas through intact skin, and these images will be compared to established clinical findings. A follow-up MSOT scan will be performed four weeks after treatment to assess changes in inflammation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented chronic graft versus host disease, Crohn's disease, or colitis.
Not a fit: Patients with tattoos over the area of inflammation, open wounds, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for detecting and monitoring inflammation in patients with chronic inflammatory diseases.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in detecting inflammation in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center, Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Lacey McNally, PhD — University of Oklahoma
- Study coordinator: Lead Clinical Coordinator
- Email: SCC-IIT-Office@ouhsc.edu
- Phone: 1-405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Graft Vs Host Disease, Colitis, Crohn Disease, Imaging device, inflammatory diseases