A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oklahoma
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events Due to MSOT Imaging
Study Overview
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 tumors and lymph nodes with tumors.
Detailed Description
This study will involve patients that are scheduled for routine standard of care surgery. It is a single-arm study 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with an identified solid tumor, i.e. breast (Stage I-IV), melanoma (Stage I-IV), HNSCC (Stage I-III), pancreatic (Stage I-III), ovarian (Stage I-IV) that is scheduled for surgical removal of the tumor and completed standard imaging prior to surgery
- •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 central nervous system tumors
- •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
Arms & Interventions
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.
Intervention: MSOT Device (Device)
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.
Intervention: Temperature Measurement (Procedure)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events Due to MSOT Imaging
Time Frame: 1-2 minutes
Adverse events as characterized by CTCAE v5.0 in patients that may result from MSOT imaging (≥44 degrees Celsius). Measurement of skin temperature pre- and post-MSOT imaging (2 measurements total) with a touch thermometer as part of the safety evaluation of the MSOT device. The thermometer will be placed onto the skin until a temperature appears, about 1 minute, and the temperature will be recorded.
Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)
Time Frame: 1-2 minutes after imaging
Percent of patients who experienced skin temperature readings \>44 degrees Celsius.
Secondary Outcomes
- Tumor Positivity From Pathology Reports Compared to MSOT Readings(6 months)
- Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.(6 months)
- Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT(6 months)