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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365413
Recruitment Status : Active, not recruiting
First Posted : April 28, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Device: MSOT Device Procedure: Temperature Measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Lacey McNally, PhD University of Oklahoma
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04365413    
Other Study ID Numbers: OU-SCC-MSOT
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of Oklahoma:
Imaging device