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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging of Tumor or Lymph node | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lacey McNally, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40967760 | Derived | McNally LR, Claros-Sorto JC, Bynum RC, Grizzle WE, Han Z, Squires R, Tippetts JD, Brannen A, Garwe T, Cohoon A, Edil BH, Holter-Chakrabarty J, Jain A. Assessment of Breast Tumors Using Multispectral Optoacoustic Tomography in a Surgical Setting. J Nucl Med. 2025 Oct 1;66(10):1597-1604. doi: 10.2967/jnumed.125.269852. |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Any participant who met inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who completed pre and post MSOT imaging temperature readings. | Posted | Count of Participants | Participants | 1-2 minutes |
|
31 days
A slight, reversible reddening and temperature increase of sensitive skin. All adverse events and expected treatment effects, including mild events, will be monitored throughout the study until discharge.
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lacey McNally | University of Oklahoma Health Sciences Center, Stephenson Cancer Center | 405-325-0789 | lacey-mcnally@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Jun 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2022 | Jun 29, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2021 | Jun 30, 2022 | ICF_002.pdf |
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| Temperature Measurement | Procedure | The temperature of the skin will be measured prior to and after MSOT imaging. |
|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Weight for two patients was not collected. | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery) | Percent of patients who experienced skin temperature readings >44 degrees Celsius. | Posted | Number | Percent of patients | 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. | Patients who underwent MSOT scanning who had usable data (no machine errors) | Posted | Median | Inter-Quartile Range | MSOT A. U. | 6 months |
|
|
|
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| 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. | Patients who underwent MSOT scanning who had usable data (no machine errors) | Posted | Median | Inter-Quartile Range | MSOT A. U. | 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. | Patients with pathology reports and viable MSOT readings | Posted | Number | percent of patients | 6 months |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
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