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

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

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.

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.

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