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Completed

NCT Number: NCT04365413

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MSOT Device

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

Procedure

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

Primary outcomes

  1. 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.

  2. 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

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

    Time frame: 6 months

    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.

  2. Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT

    Time frame: 6 months

    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.

  3. Tumor Positivity From Pathology Reports Compared to MSOT Readings

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: OU-SCC-MSOT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 28, 2020
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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