Crohn Disease Clinical Trial
— SCC-O-FLAMEOfficial 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5 minutes for an MSOT image (up to 48 hours post-image) | |
Primary | 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. | 5 minutes for an MSOT image (up to 48 hours post-image) | |
Primary | 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. | 1-2 minutes before the MSOT image. | |
Primary | 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. | 1-2 minutes after the MSOT image. | |
Primary | 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. | 1-2 minutes before the MSOT image. | |
Primary | 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. | 1-2 minutes after the MSOT image. | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
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