A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors
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|ClinicalTrials.gov Identifier: NCT04365413|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2020
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Device: MSOT Device Procedure: Temperature Measurement||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)|
|Actual Study Start Date :||July 22, 2020|
|Actual Primary Completion Date :||July 12, 2021|
|Estimated Study Completion Date :||July 12, 2022|
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.
- Adverse Events due to MSOT imaging [ Time Frame: 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.
- Detection of Residual Tumor after Surgery [ Time Frame: 6 months ]
Percent residual tumor after resection based on MSOT imaging will be calculated. Tumor positivity based on signal detection using MSOT will be correlated with that obtained from standard clinical laboratory techniques.
Medical record review will occur up to 6 months to allow for follow-up pathology assessments to be gathered and provide information to allow for analyses to be performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365413
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73117|
|Principal Investigator:||Lacey McNally, PhD||University of Oklahoma|