Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPhotoacoustic Imaging
Undergo PAI
Undergo ALTENS
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate | Up to 6 months after treatment completion | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. |
| Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate | Up to 2 years | Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility of serial PAI-based oxygen saturation (%sO2) measurements | Up to 2 years | Descriptive statistics (means, medium) will be used to summarize percent of SO2 |
| Changes in hemoglobin (hbt) measurements | Up to 2 years | Compare hemoglobin measurements between baseline until end of study |
Countries
United States
Outcome results
None listed