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Search / Trial NCT05333978

Optoacoustic Detection of Inflammation Using MSOT Device

Launched by UNIVERSITY OF OKLAHOMA · Apr 11, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Imaging Device Inflammatory Diseases

ClinConnect Summary

This clinical trial is investigating a new imaging tool called multispectral optoacoustic tomography (MSOT) to see how well it can detect inflammation in patients with certain conditions, specifically chronic graft versus host disease (GVHD) affecting the skin or digestive system, Crohn's disease, or colitis. The goal is to determine if this experimental device is safe and effective for monitoring these types of inflammation.

To participate in the trial, patients should be at least 18 years old and have a documented case of one of the conditions mentioned. They must also have acceptable blood health, meaning their hemoglobin levels should be at least 7.0 mg/dL. Participants will need to agree to follow the study procedures and provide informed consent, which means they understand what the study involves. It’s important to note that individuals with tattoos over the inflamed area, pregnant or breastfeeding women, and those with certain skin conditions or illnesses may not be eligible. Throughout the study, participants can expect to undergo imaging sessions using the MSOT device to help researchers gather important data.

Gender

ALL

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

About University Of Oklahoma

The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.

Locations

Oklahoma City, Oklahoma, United States

Oklahoma City, Oklahoma, United States

Patients applied

0 patients applied

Trial Officials

Lacey McNally, PhD

Principal Investigator

University of Oklahoma

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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