Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer
NCT Number: NCT06477003
Acronym: OUSCCMOTORX
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Interventions: DEVICE: Multispectral Optoacoustic Tomography|PROCEDURE: Temperature Measurement
Sponsor: University of Oklahoma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2027-08
Locations: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States

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.

Primary Outcome Measures: 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: 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