A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors (OU-SCC-MSOT)

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Device: MSOT Device; Procedure: Temperature Measurement

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Procedure: Temperature Measurement; The temperature of the skin will be measured prior to and after MSOT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1-2 minutes after imaging

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months
Tumor Positivity From Pathology Reports Compared to MSOT Readings	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.	6 months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Lacey McNally, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Imaging device
• Other Study ID Numbers: OU-SCC-MSOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes