NCT04365413

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

A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-22
• Primary completion: 2021-07-12
• Completion: 2022-12-12
• First posted: 2020-04-28
• Last updated: 2023-12-14
• Results posted: 2022-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study