Head and Neck Squamous Cell CarcinomaOUSCCMOTORXNCT06477003
Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer
A study testing Multispectral Optoacoustic Tomography and Temperature Measurement in people with Head and Neck Squamous Cell Carcinoma, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Multispectral Optoacoustic Tomography and Temperature Measurement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
Read the 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
- Being tested
- Multispectral Optoacoustic Tomography, Temperature Measurement
- Keywords
- Imaging device
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacoustic TomographyDevice
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.
Temperature MeasurementProcedure or surgery
The temperature of the skin will be measured prior to and after MSOT imaging.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - surgery patients | Experimental | 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. Receives: Device: Multispectral Optoacoustic Tomography; Procedure: Temperature Measurement |
| Arm 2 - radiotherapy patients | Experimental | 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. Receives: Device: Multispectral Optoacoustic Tomography; Procedure: Temperature Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-2 minutes after the MSOT image
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Why it stopped: Administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Henson, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477003
- Sponsor's protocol ID
- OU-SCC-MOTORX
- Acronym
- OUSCCMOTORX
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multispectral Optoacoustic Tomography for the Detection of Extranodal Extension and Radiation Induced Fibrosis in Head and Neck Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT06477003
- Acronym / sponsor ID
- OUSCCMOTORX / OU-SCC-MOTORX
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Imaging device
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Administrative reasons.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - surgery patients | Experimental | Device: Multispectral Optoacoustic Tomography, Procedure: Temperature Measurement70 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. |
| Arm 2 - radiotherapy patients | Experimental | Device: Multispectral Optoacoustic Tomography, Procedure: Temperature Measurement30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacoustic TomographyThe MSOT device will be used to take images of the tumor or affected lymph nodes of patients with head and neck squamous cell carcinoma. | Device | Arm 1 - surgery patients, Arm 2 - radiotherapy patients |
| Temperature MeasurementThe temperature of the skin will be measured prior to and after MSOT imaging. | Procedure or surgery | Arm 1 - surgery patients, Arm 2 - radiotherapy patients |
Primary outcome
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
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.
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.
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.
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.
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.
5 secondary outcomes
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)
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)
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)
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)
Degree of bias for the comparison of MSOT images with CT scans (or other imaging modalities if necessary)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Henson, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral Optoacoustic Tomography and Temperature Measurement in people with Head and Neck Squamous Cell Carcinoma, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events due to MSOT imaging prior to surgery (time frame: 30 minutes for an MSOT image (up to 24 hours post-image)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.