Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer

University of Oklahoma100 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

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

The temperature of the skin will be measured prior to and after MSOT imaging.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

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

Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 12 months after end of radiation therapy.

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

Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 18 months after end of radiation therapy.

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

Area of fibrosis will be measured by MSOT scans and compared to data from physical examination 24 months after end of radiation therapy.

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)

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.

Time frame: 2 years