A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors (OU-SCC-MSOT)

University of Oklahoma (OU)

Status: Completed

Conditions: Solid Tumor

Treatments: Device: MSOT Device; Procedure: Temperature Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04365413

OU-SCC-MSOT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Imaging of Tumor or Lymph node

Experimental group

Description:

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.

Treatment:

Procedure: Temperature Measurement

Device: MSOT Device