TerminatedNot Applicable

Optoacoustic Detection of Inflammation Using MSOT Device

Stopped: Administrative Reasons

United States29 participantsStarted 2022-05-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events due to MSOT imaging post enrollment.

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

Adverse Events due to MSOT imaging 4 weeks after treatment.

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

Measurement of skin temperature before first MSOT image post enrollment.

Timeframe: 1-2 minutes before the MSOT image.

Measurement of skin temperature after first MSOT image post enrollment.

Timeframe: 1-2 minutes after the MSOT image.

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

Timeframe: 1-2 minutes before the MSOT image.

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

Timeframe: 1-2 minutes after the MSOT image.

Trial details

NCT IDNCT05333978

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-20

View on ClinicalTrials.gov More Graft Vs Host Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Adverse Events due to MSOT imaging post enrollment.

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

Adverse Events due to MSOT imaging 4 weeks after treatment.

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

Measurement of skin temperature before first MSOT image post enrollment.

Timeframe: 1-2 minutes before the MSOT image.

Measurement of skin temperature after first MSOT image post enrollment.

Timeframe: 1-2 minutes after the MSOT image.

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

Timeframe: 1-2 minutes before the MSOT image.

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

Timeframe: 1-2 minutes after the MSOT image.