Trial Outcomes & Findings for A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors (NCT NCT04365413)

Last Updated: 2023-12-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

1-2 minutes

Results posted on

2023-12-14

Participant Flow

Participants were enrolled on this study at the University of Oklahoma Stephenson Cancer Center between July 2020 and July 2021. The first participant was enrolled on July 22th, 2020 and the last participant was enrolled on July 12th, 2021.

Of the 54 enrolled participants, 49 participants met the inclusion criteria, and 5 were designated as screen fails. Of the 49 participants, 45 were assigned to be scanned by the MSOT device and had skin temperature measurements taken, and 4 did not continue on the study.

Participant milestones

Participant milestones
Measure	Imaging of Tumor or Lymph Node Using MSOT and Temperature Measurement 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.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Weight for two patients was not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imaging of Tumor or Lymph Node n=49 Participants 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.
Age, Continuous	59.59 years STANDARD_DEVIATION 11.848 • n=49 Participants
Sex: Female, Male Female	49 Participants n=49 Participants
Sex: Female, Male Male	0 Participants n=49 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=49 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=49 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=49 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=49 Participants
Race (NIH/OMB) Asian	3 Participants n=49 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=49 Participants
Race (NIH/OMB) Black or African American	4 Participants n=49 Participants
Race (NIH/OMB) White	37 Participants n=49 Participants
Race (NIH/OMB) More than one race	0 Participants n=49 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=49 Participants
Region of Enrollment United States	49 Participants n=49 Participants
Body Mass Index (BMI)	30.15 kg/m^2 STANDARD_DEVIATION 7.485 • n=47 Participants • Weight for two patients was not collected.

PRIMARY outcome

Timeframe: 1-2 minutes

Population: Patients who completed pre and post MSOT imaging temperature readings.

Outcome measures

Outcome measures
Measure	Imaging of Tumor or Lymph Node n=45 Participants 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.
Number of Participants With Adverse Events Due to MSOT Imaging	0 Participants

PRIMARY outcome

Timeframe: 1-2 minutes after imaging

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

Outcome measures

Outcome measures
Measure	Imaging of Tumor or Lymph Node n=45 Participants 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.
Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)	0 Percent of patients

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome measures
Measure	Imaging of Tumor or Lymph Node n=43 Participants 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.
Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.	0.0687 MSOT A. U. Interval 0.0407 to 0.1019

SECONDARY outcome

Timeframe: 6 months

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

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.

Outcome measures

Outcome measures
Measure	Imaging of Tumor or Lymph Node n=43 Participants 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.
Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT	0.0420 MSOT A. U. Interval 0.0293 to 0.0845

SECONDARY outcome

Timeframe: 6 months

Population: Patients with pathology reports and viable 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.

Outcome measures

Outcome measures
Measure	Imaging of Tumor or Lymph Node n=43 Participants 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.
Tumor Positivity From Pathology Reports Compared to MSOT Readings	100 percent of patients

Adverse Events

Imaging of Tumor or Lymph Node

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lacey McNally

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Phone: 405-325-0789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place