A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
Time Frame: 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
Time Frame: 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 Outcomes
- Changes in hemoglobin (hbt) measurements(Up to 2 years)
- Utility of serial PAI-based oxygen saturation (%sO2) measurements(Up to 2 years)