A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors

University of Oklahoma54 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

MSOT DeviceDEVICE

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 MeasurementPROCEDURE

The temperature of the skin will be measured prior to and after MSOT imaging.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events Due to MSOT Imaging

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.

Time frame: 1-2 minutes

Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)

Percent of patients who experienced skin temperature readings \>44 degrees Celsius.

Time frame: 1-2 minutes after imaging

Secondary Outcomes

Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.

MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of oxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of oxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR reported.

Time frame: 6 months

Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT

MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of deoxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of deoxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR is reported.

Data from ClinicalTrials.gov

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