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.

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.

MSOT Device

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

Temperature Measurement

Lacey McNally, PhD

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.

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

A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)

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.

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

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.

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.

Tumor positivity will be compared (yes/no) from the standard pathology report with the MSOT readings. Percent of patients with matching readings will be calculated and reported.

University of Oklahoma

A slight, reversible reddening and temperature increase of sensitive skin. All adverse events and expected treatment effects, including mild events, will be monitored throughout the study until discharge.

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.

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.

Imaging of Tumor or Lymph Node

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Weight for two patients was not collected.

Body Mass Index (BMI)

Any participant who met inclusion criteria.

Lacey McNally

Patients who completed pre and post MSOT imaging temperature readings.

Number of Participants With Adverse Events Due to MSOT Imaging

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

Patients who underwent MSOT scanning who had usable data (no machine errors)

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

Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT

Patients with pathology reports and viable MSOT readings

Tumor Positivity From Pathology Reports Compared to MSOT Readings

The MSOT Device was 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.

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

Spots Global Cancer Trial Database for A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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