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

August 17, 2026 updated by: University of Oklahoma

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events due to MSOT imaging prior to surgery
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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.
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 1-2 minutes before the MSOT image.
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
Time Frame: 1-2 minutes after the MSOT image
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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
Time Frame: 30 minutes for an MSOT image (up to 24 hours post-image)
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)
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Henson, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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