Graft Vs Host DiseaseOU-SCC-O-FLAMENCT05333978
Optoacoustic Detection of Inflammation Using MSOT Device
A study testing MSOT Device and Temperature Measurement in people with Graft Vs Host Disease and Colitis, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Vs Host Disease, Colitis, Crohn Disease
- What is being tested?
- MSOT Device and Temperature Measurement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 20 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73014
About this study
Official title: Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography
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.
Read the 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 correlate with clinical findings identified via pathology or radiology.
The device will be used to obtain images of the areas of inflammation in the above patients for investigational use only, to compare to clinical pathology and patient's medical record. Patients will go through standard care procedures prior to imaging. Medically established diagnostic procedures will be used to detect areas of inflammation associated with GVHD, Crohn's, or colitis. Images using the MSOT device will be obtained through intact skin. A second MSOT scan will be performed for all patients 4 weeks post treatment. The temperature of the patient's skin will also be measured prior to and after MSOT imaging.
MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.
- Conditions
- Graft Vs Host Disease, Colitis, Crohn Disease
- Being tested
- MSOT Device, Temperature Measurement
- Keywords
- Imaging device, inflammatory diseases
- Medical subject headings
- Graft vs Host Disease, Colitis, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSOT DeviceDevice
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.
Temperature MeasurementProcedure or surgery
The temperature of the skin will be measured prior to and after each instance of MSOT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MSOT Device; Procedure: Temperature Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Compare clinical grading (positivity/negativity; 1-4) and pathologic severity of skin and GI GVHD with extent of disease defined by clinical grading, and compare to oxy- and deoxy-hemoglobin values using MSOT localization.
Measured: 6 months
Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease.
Compare clinical grading (positivity/negativity) of Crohn's disease with severity of Crohn's, and extent of disease defined by clinical grading and compare to oxy- and deoxy-hemoglobin values using MSOT localization.
Measured: 6 months
Comparison of MSOT images to Clinical Pathology Reports for severity of colitis.
Compare clinical grading (positivity/negativity) of colitis with severity and extent of disease defined by clinical grading, and compare to oxy- and deoxy-hemoglobin values using MSOT localization.
Measured: 6 months
Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports
Compare mean/median collagen deposition values obtained from MSOT across GVHD grade/response.
Measured: 6 months
Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports
Compare mean/median collagen deposition values obtained from MSOT across Crohn's grade/response.
Measured: 6 months
Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports
Compare mean/median collagen deposition values obtained from MSOT across colitis grade/response.
Measured: 6 months
Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Compare mean/median oxy- and deoxy-hemoglobin values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected at diagnosis in patients with acute or chronic GVHD.
Measured: 6 months
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Compare mean/median collagen deposition values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected at diagnosis in patients with acute or chronic GVHD.
Measured: 6 months
Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
Compare mean/median oxy- and deoxy-hemoglobin obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected 4 weeks after treatment in patients with acute or chronic GVHD.
Measured: 6 months
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
Compare mean/median collagen deposition values obtained from MSOT images across MAGIC score/NIH consensus and Johns Hopkins prognosis criteria collected 4 weeks after treatment in patients with acute or chronic GVHD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start31 May 2022
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Why it stopped: Administrative Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lacey McNally, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333978
- Sponsor's protocol ID
- OU-SCC-O-FLAME
- Acronym
- OU-SCC-O-FLAME
- Status last verified
- May 2026
- First submitted
- 21 Feb 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography
- ClinicalTrials.gov ID
- NCT05333978
- Acronym / sponsor ID
- OU-SCC-O-FLAME / OU-SCC-O-FLAME
- Conditions
- Graft Vs Host Disease, Colitis, Crohn Disease
- Keywords
- Imaging device, inflammatory diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Reasons
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 correlate with clinical findings identified via pathology or radiology.
The device will be used to obtain images of the areas of inflammation in the above patients for investigational use only, to compare to clinical pathology and patient's medical record. Patients will go through standard care procedures prior to imaging. Medically established diagnostic procedures will be used to detect areas of inflammation associated with GVHD, Crohn's, or colitis. Images using the MSOT device will be obtained through intact skin. A second MSOT scan will be performed for all patients 4 weeks post treatment. The temperature of the patient's skin will also be measured prior to and after MSOT imaging.
MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging of Inflammatory region | Experimental | Device: MSOT Device, Procedure: Temperature MeasurementInflammatory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSOT DeviceThe 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. | Device | Imaging of Inflammatory region |
| Temperature MeasurementThe temperature of the skin will be measured prior to and after each instance of MSOT imaging. | Procedure or surgery | Imaging of Inflammatory region |
Primary outcome
Adverse Events due to MSOT imaging post enrollment.
Time frame: 5 minutes for an MSOT image (up to 48 hours post-image)
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.
Adverse Events due to MSOT imaging 4 weeks after treatment.
Time frame: 5 minutes for an MSOT image (up to 48 hours post-image)
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.
Measurement of skin temperature before first MSOT image post enrollment.
Time frame: 1-2 minutes before the MSOT image.
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.
Measurement of skin temperature after first MSOT image post enrollment.
Time frame: 1-2 minutes after the MSOT image.
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.
Measurement of skin temperature before second MSOT image post-treatment.
Time frame: 1-2 minutes before the MSOT image.
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.
Measurement of skin temperature after second MSOT image post-treatment.
Time frame: 1-2 minutes after the MSOT image.
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.
10 secondary outcomes
Comparison of MSOT images to Clinical Pathology Reports for Clinical Grading of Graft Versus Host Disease.
Time frame: 6 months
Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease.
Time frame: 6 months
Comparison of MSOT images to Clinical Pathology Reports for severity of colitis.
Time frame: 6 months
Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports
Time frame: 6 months
Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports
Time frame: 6 months
Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports
Time frame: 6 months
Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Time frame: 6 months
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Time frame: 6 months
Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
Time frame: 6 months
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Administrative Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lacey McNally, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSOT Device and Temperature Measurement in people with Graft Vs Host Disease and Colitis, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Administrative Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events due to MSOT imaging post enrollment. (time frame: 5 minutes for an MSOT image (up to 48 hours post-image)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.