Multispectral Optoacoustic Tomography in Head and Neck Squamous Cell Cancer

NCT ID: NCT06477003

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Multispectral Optoacoustic Tomography

Intervention Type DEVICE

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 Measurement

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Multispectral Optoacoustic Tomography

Intervention Type DEVICE

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 Measurement

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

Temperature Measurement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Henson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ingrid Block

Role: CONTACT

1-405-271-8777

Lead Nurse

Role: CONTACT

1-405-271-8777

Facility Contacts

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Christina Henson, MD

Role: primary

405-271-8001 ext. 52473

Other Identifiers

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OU-SCC-MOTORX

Identifier Type: -

Identifier Source: org_study_id

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