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

• Sponsor: University of Oklahoma (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04365413
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Jul 22, 2020
• Actual Primary Completion Date: Jul 12, 2021
• Anticipated Study Completion Date: Jul 12, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

Secondary Outcome Measures

1. Detection of Residual Tumor after Surgery [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oklahoma	Oklahoma City	Oklahoma	United States	73117

Sponsors and Collaborators

• University of Oklahoma

Investigators

• Principal Investigator: Lacey McNally, PhD, University of Oklahoma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT04365413
• Other Study ID Numbers: OU-SCC-MSOT
• First Posted: Apr 28, 2020
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Oklahoma: Imaging device

Study Results

No Results Posted as of Sep 29, 2021