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Device

Optoacoustic Tomography for Head and Neck Cancer (OUSCCMOTORX Trial)

N/A

Waitlist Available

Led By Christina Henson, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinically confirmed node positive head and neck squamous cell cancer

At least 18 years-of-age at the time of signature of the informed consent form (ICF)

Must not have

History of previous head and neck radiotherapy

Intent of treatment palliative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study a new device called Multispectral Optoacoustic Tomography (MSOT) to see if it can accurately detect and evaluate lymph nodes in the neck that may be affected

Who is the study for?

This trial is for patients with metastatic head and neck squamous cell carcinomas. Specific eligibility criteria are not provided, but typically participants would need to have the condition under study and meet certain health requirements.

What is being tested?

The trial is testing Multispectral Optoacoustic Tomography (MSOT), a device that may help identify affected neck lymph nodes more accurately in these cancer patients. Temperature measurement is also part of the intervention being studied.

What are the potential side effects?

Since MSOT is an imaging technique and not a drug, side effects might be minimal or related to the procedure itself rather than systemic reactions like those seen with medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer in the head or neck area has spread to my lymph nodes.

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I am 18 years old or older.

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My treatment is aimed at curing my disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiotherapy for head or neck cancer before.

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My treatment is aimed at easing symptoms, not curing the disease.

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I am currently pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events due to MSOT imaging after the completion of radiotherapy treatment.

Adverse events due to MSOT imaging during week 4 of radiotherapy

Adverse events due to MSOT imaging prior to radiotherapy

+3 more

Secondary study objectives

Assessment of radiation induced fibrosis via MSOT imaging in first follow up scan for Arm 2

Assessment of radiation induced fibrosis via MSOT imaging in fourth follow up scan for Arm 2

Assessment of radiation induced fibrosis via MSOT imaging in second follow up scan for Arm 2

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 - radiotherapy patientsExperimental Treatment2 Interventions

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 II: Arm 1 - surgery patientsExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Multispectral Optoacoustic Tomography

2018

N/A

~30

Temperature Measurement

2020

N/A

~60