A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
NCT ID: NCT04365413
Last Updated: 2023-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2020-07-22
2022-12-12
Brief Summary
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Detailed Description
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The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical record. All images will be obtained pre- and post-surgery in a closed surgical patient. 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Imaging of Tumor or Lymph node
Tumors and/or lymph nodes of patients scheduled for standard of care surgery will be imaged using the MSOT device before and after surgery.
The temperature of their skin prior to and after MSOT imaging will also be measured.
MSOT Device
The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.
Temperature Measurement
The temperature of the skin will be measured prior to and after MSOT imaging.
Interventions
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MSOT Device
The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.
Temperature Measurement
The temperature of the skin will be measured prior to and after MSOT imaging.
Eligibility Criteria
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Inclusion Criteria
* Have acceptable hematologic status \[total hemoglobin (tHb) ≥ 10 mg/dL\]
* Patients ≥ 18 yrs of age
* Patient provided a signed and dated informed consent
* Willing to comply with study procedures and be available for the duration of the study
* Ability to understand and the willingness to sign an IRB-approved informed consent document.
Exclusion Criteria
* Patients with a tattoo over the surgical site
* Pregnant women
* Women who are breastfeeding
* Systemic or local infection
* Any systemic anomaly during the pre-op assessment preventing patient participation in the study
* Any febrile illness that precludes or delays participation preoperatively
* Anything that would put the participant at increased risk or preclude compliance with the study
* Patients with Stage IV pancreatic cancer, Stage IV HNSCC are not surgical candidates and therefore excluded from this study
18 Years
ALL
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Lacey McNally, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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OU-SCC-MSOT
Identifier Type: -
Identifier Source: org_study_id