Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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This trial studies how well photoacoustic imaging works in measuring tumors and normal tissue in patients with head and neck cancer. Photoacoustic imaging (PAI) is a low-risk imaging method that provides information about the oxygenation of tissues using a combination of light and ultrasound techniques. This study may help doctors determine if PAI is correlated with clinical responses of both tumor (for example: shrinking, swelling or disappearing) and normal tissues (for example: skin redness, dry mouth, appearance of sores, healing of skin or mucosa). If there is a correlation with clinical responses, then doctors may develop PAI as method for measuring response to earlier treatment.

Detailed Description
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PRIMARY OBJECTIVE: I. Define the feasibility of the current photoacoustic imaging (PAI) technology in head and neck (H&N) cancer patients. SECONDARY OBJECTIVE: I. Define the utility of the current PAI in H&N cancer patients. OUTLINE: PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy. PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up.

Official Title
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A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients

Conditions
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Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient

Intervention / Treatment
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* Procedure: Photoacoustic Imaging
* Procedure: Transcutaneous Acupoint Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No restriction on race or ethnic background Subject must understand the investigational nature of the study and sign an independent ethics committee/institutional review board approved written informed consent prior to receiving any study related procedure FOR CANCER PATIENTS IN THE H&N RADIATION GROUP (PART I): Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) getting chemoradiation therapy Presence of neck nodes or laryngeal tumor superficial enough (within 2-3 cm of skin surface) to allow imaging by photoacoustic ultrasound (PA-US) FOR ALTENS PATIENTS (PART II): History of prior radiation therapy with xerostomia requiring ALTENS Exclusion Criteria: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Unwilling or unable to follow protocol requirements or provide consent Any condition which in the Investigator?s opinion deems the subject an unsuitable candidate to undergo imaging procedure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (PAI, ALTENS)<br>PART I: Patients undergo PAI before the start of chemoradiation therapy, weekly during 7 weeks of chemoradiation, and again 3-4 months after completion of chemoradiation therapy. PART II (CANCER-FREE WITH XEROSTOMIA): Patients undergo PAI at baseline, up to twice during acupuncture-like transcutaneous nerve stimulation (ALTENS) therapy, once after ALTENS, and at 3-6 months follow up. | Procedure: Photoacoustic Imaging<br>* Undergo PAI<br>Procedure: Transcutaneous Acupoint Electrical Stimulation<br>* Undergo ALTENS<br>* Other names: TAES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. | Up to 6 months after treatment completion | 
| Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of serial PAI-based oxygen saturation (%sO2) measurements | Descriptive statistics (means, medium) will be used to summarize percent of SO2 | Up to 2 years | 
| Changes in hemoglobin (hbt) measurements | Compare hemoglobin measurements between baseline until end of study | Up to 2 years |