Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer (OUSCCMOTORX)

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

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.

Study Overview

• Status: Suspended
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Procedure: Temperature Measurement; Device: Multispectral Optoacoustic Tomography

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinically confirmed node positive head and neck squamous cell cancer
• Written informed consent signed and dated by the patient prior to the performance of the MSOT
• At least 18 years-of-age at the time of signature of the informed consent form (ICF)
• Patients planned for curative intent therapy
• Patient available for the study duration
• Patients of childbearing potential must have a negative pregnancy test prior to the study entry.
• Patients of childbearing potential must use an effective form of contraceptive as per the protocol.

Exclusion Criteria:

• History of previous head and neck radiotherapy
• Intent of treatment palliative
• Women who are pregnant
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of the investigational regimen should be included.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - surgery patients; 70 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive surgery will be imaged using the MSOT device prior to surgery. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.	Procedure: Temperature Measurement; The temperature of the skin will be measured prior to and after MSOT imaging.; 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.
Experimental: Arm 2 - radiotherapy patients; 30 patients with clinically confirmed metastatic head and neck squamous cell carcinomas (N+ HNSCC) planned for definitive radiotherapy (RT) (+/- chemo) will be imaged using the MSOT device before, during, and after radiotherapy. 15 patients will be treated with photon RT and 15 patients will be treated with proton therapy. Skin temperature will be measured prior to and after MSOT imaging to assess for safety.	Procedure: Temperature Measurement; The temperature of the skin will be measured prior to and after MSOT imaging.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events due to MSOT imaging prior to surgery	Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to surgery	30 minutes for an MSOT image (up to 24 hours post-image)
Adverse events due to MSOT imaging prior to radiotherapy	Proportion of patients that experience adverse events resulting from MSOT imaging. The first MSOT image will be taken prior to radiotherapy.	30 minutes for an MSOT image (up to 24 hours post-image)
Adverse events due to MSOT imaging during week 4 of radiotherapy	Proportion of patients that experience adverse events resulting from MSOT imaging. The second MSOT image will be taken during week 4 of radiotherapy for patients enrolled in Arm 2.	30 minutes for an MSOT image (up to 24 hours post-image)
Adverse events due to MSOT imaging after the completion of radiotherapy treatment.	Proportion of patients that experience adverse events resulting from MSOT imaging. The third MSOT image will be taken after conclusion of radiotherapy for patients enrolled in Arm 2.	30 minutes for an MSOT image (up to 24 hours post-image)
Measurement of skin temperature before MSOT imaging	Number of patients with skin temperatures measured pre-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) before the MSOT image is obtained.	1-2 minutes before the MSOT image.
Measurement of skin temperature after MSOT imaging	Number of patients with skin temperatures measured post-MSOT imaging with a touch thermometer as part of the safety evaluation of the MSOT device. A temperature measurement will be recorded by placing the touch thermometer onto the skin until a temperature appears (about 30 seconds) after the MSOT image is obtained.	1-2 minutes after the MSOT image

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2	Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 6 months after end of radiation therapy.	30 minutes for an MSOT image (up to 24 hours post-image)
Assessment of radiation induced fibrosis via MSOT imaging in second follow up scan for Arm 2	Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 12 months after end of radiation therapy.	30 minutes for an MSOT image (up to 24 hours post-image)
Assessment of radiation induced fibrosis via MSOT imaging in third follow up scan for Arm 2	Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 18 months after end of radiation therapy.	30 minutes for an MSOT image (up to 24 hours post-image)
Assessment of radiation induced fibrosis via MSOT imaging in fourth follow up scan for Arm 2	Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 24 months after end of radiation therapy.	30 minutes for an MSOT image (up to 24 hours post-image)
Degree of bias for the comparison of MSOT images with CT scans (or other imaging modalities if necessary)	For Arm 2 of the study, tumor volume based on MSOT and standard CT measurements will be compared to PET Scan reference standard. The degree of bias for each imaging technique will be assessed using Bland-Altman plots and will be subsequently compared between the two imaging techniques.	2 years

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Christina Henson, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Imaging device
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: OU-SCC-MOTORX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes