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

Roswell Park Cancer Institute14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Head and Neck Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 2 years

Secondary Outcomes

Utility of serial PAI-based oxygen saturation (%sO2) measurements

Descriptive statistics (means, medium) will be used to summarize percent of SO2

Time frame: Up to 2 years

Changes in hemoglobin (hbt) measurements

Compare hemoglobin measurements between baseline until end of study

Time frame: Up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes