NCT06477003

Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer

Multispectral Optoacoustic Tomography for the Detection of Extranodal Extension and Radiation Induced Fibrosis in Head and Neck Squamous Cell Cancer

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to assess the safety and evaluate the potential of the Multispectral Optoacoustic Tomography (MSOT) device to more precisely identify and assess the neck lymph nodes which might be affected in patients with metastatic head and neck squamous cell carcinomas.

Detailed description

This is a 2-Arm investigational device study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and to determine the ability of MSOT imaging data to correlate with clinical findings identified via pathology. Imaging with the MSOT device is expected to obtain information about the number, size, and appearance of the lymph nodes in the neck. 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 records. All images will be obtained pre-surgery for Arm 1 patients (undergoing surgery for their cancer) and before, during and after radiotherapy in Arm 2 patients (undergoing radiotherapy treatment for their cancer). The temperature of the patient's skin will also be measured prior to and after each MSOT scan. Once radiotherapy treatment has completed, images using the MSOT device will be obtained every 6 months for 2 years to assess for radiation induced fibrosis. MSOT scans will be for research only and no treatment decisions will be based on the MSOT images obtained.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	Multispectral Optoacoustic Tomography	The MSOT device will be used to take images of the tumor or affected lymph nodes of patients with head and neck squamous cell carcinoma.
PROCEDURE	Temperature Measurement	The temperature of the skin will be measured prior to and after MSOT imaging.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2024-06-27
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study