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

Solid Tumor Clinical Trial

— OU-SCC-MSOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365413
• Other study ID #: OU-SCC-MSOT
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: December 12, 2022

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 12, 2022
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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