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Optoacoustic Detection of Inflammation Using MSOT Device (SCC-O-FLAME)

Primary Purpose

Graft Vs Host Disease, Colitis, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSOT Device
Temperature Measurement
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Graft Vs Host Disease focused on measuring Imaging device, inflammatory diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OU Health Stephenson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging of Inflammatory region

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 21, 2022
Last Updated
October 9, 2023
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05333978
Brief Title
Optoacoustic Detection of Inflammation Using MSOT Device
Acronym
SCC-O-FLAME
Official Title
Optoacoustic Detection of Inflammation Using Multispectral Optoacoustic Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
April 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Vs Host Disease, Colitis, Crohn Disease
Keywords
Imaging device, inflammatory diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging of Inflammatory region
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MSOT Device
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Temperature Measurement
Intervention Description
The temperature of the skin will be measured prior to and after each instance of MSOT imaging.
Primary Outcome Measure Information:
Title
Adverse Events due to MSOT imaging post enrollment.
Description
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.
Time Frame
5 minutes for an MSOT image (up to 48 hours post-image)
Title
Adverse Events due to MSOT imaging 4 weeks after treatment.
Description
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.
Time Frame
5 minutes for an MSOT image (up to 48 hours post-image)
Title
Measurement of skin temperature before first MSOT image post enrollment.
Description
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.
Time Frame
1-2 minutes before the MSOT image.
Title
Measurement of skin temperature after first MSOT image post enrollment.
Description
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.
Time Frame
1-2 minutes after the MSOT image.
Title
Measurement of skin temperature before second MSOT image post-treatment.
Description
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.
Time Frame
1-2 minutes before the MSOT image.
Title
Measurement of skin temperature after second MSOT image post-treatment.
Description
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.
Time Frame
1-2 minutes after the MSOT image.
Secondary Outcome Measure Information:
Title
Comparison of MSOT images to Clinical Pathology Reports for Clinical Grading of Graft Versus Host Disease.
Description
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.
Time Frame
6 months
Title
Comparison of MSOT images to Clinical Pathology Reports for severity of Crohn's disease.
Description
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.
Time Frame
6 months
Title
Comparison of MSOT images to Clinical Pathology Reports for severity of colitis.
Description
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.
Time Frame
6 months
Title
Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports
Description
Compare mean/median collagen deposition values obtained from MSOT across GVHD grade/response.
Time Frame
6 months
Title
Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports
Description
Compare mean/median collagen deposition values obtained from MSOT across Crohn's grade/response.
Time Frame
6 months
Title
Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports
Description
Compare mean/median collagen deposition values obtained from MSOT across colitis grade/response.
Time Frame
6 months
Title
Comparison of oxy- and deoxy-hemoglobin values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Description
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.
Time Frame
6 months
Title
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients at diagnosis.
Description
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.
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Title
Comparison of collagen deposition values from MSOT images to various prognosis criteria collected on the study for GVHD patients 4 weeks after treatment.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lead Clinical Coordinator
Phone
1-405-271-8777
Email
SCC-IIT-Office@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lacey McNally, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lacey McNally
Phone
405-325-0789
Email
lacey-mcnally@ouhsc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Optoacoustic Detection of Inflammation Using MSOT Device

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