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Trial Title:
Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer
NCT ID:
NCT06477003
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Squamous Cell
Conditions: Keywords:
Imaging device
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Multispectral Optoacoustic Tomography
Description:
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.
Arm group label:
Arm 1 - surgery patients
Arm group label:
Arm 2 - radiotherapy patients
Intervention type:
Procedure
Intervention name:
Temperature Measurement
Description:
The temperature of the skin will be measured prior to and after MSOT imaging.
Arm group label:
Arm 1 - surgery patients
Arm group label:
Arm 2 - radiotherapy patients
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Contact:
Last name:
Christina Henson, MD
Phone:
405-271-8001
Phone ext:
52473
Email:
christina-henson@ouhsc.edu
Start date:
December 2024
Completion date:
August 2027
Lead sponsor:
Agency:
University of Oklahoma
Agency class:
Other
Source:
University of Oklahoma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06477003
