Solid Tumor
Conditions
Keywords
Imaging device
Brief 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.
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.
Interventions
DEVICEMSOT 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.
PROCEDURETemperature Measurement
The temperature of the skin will be measured prior to and after MSOT imaging.
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events Due to MSOT Imaging | 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. |
| Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery) | 1-2 minutes after imaging | Percent of patients who experienced skin temperature readings \>44 degrees Celsius. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device. | 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. |
| Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT | 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. |
| Tumor Positivity From Pathology Reports Compared to MSOT Readings | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | Imaging of Tumor or Lymph Node |
|---|---|
| Age, Continuous | 59.59 years STANDARD_DEVIATION 11.848 |
| Body Mass Index (BMI) | 30.15 kg/m^2 STANDARD_DEVIATION 7.485 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment United States | 49 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)
Percent of patients who experienced skin temperature readings \>44 degrees Celsius.
Time frame: 1-2 minutes after imaging
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Imaging of Tumor or Lymph Node | Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery) | 0 Percent of patients |
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.
Time frame: 1-2 minutes
Population: Patients who completed pre and post MSOT imaging temperature readings.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imaging of Tumor or Lymph Node | Number of Participants With Adverse Events Due to MSOT Imaging | 0 Participants |
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.
Time frame: 6 months
Population: Patients who underwent MSOT scanning who had usable data (no machine errors)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Imaging of Tumor or Lymph Node | Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT | 0.0420 MSOT A. U. |
p-value: <0.0001Paired t-test
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.
Time frame: 6 months
Population: Patients who underwent MSOT scanning who had usable data (no machine errors)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Imaging of Tumor or Lymph Node | Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device. | 0.0687 MSOT A. U. |
p-value: <0.0001Paired t-test
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.
Time frame: 6 months
Population: Patients with pathology reports and viable MSOT readings
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Imaging of Tumor or Lymph Node | Tumor Positivity From Pathology Reports Compared to MSOT Readings | 100 percent of patients |