Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
Verified date | April 2023 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | December 29, 2022 |
Est. primary completion date | December 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Changes in hemoglobin (hbt) measurements | Compare hemoglobin measurements between baseline until end of study | Up to 2 years |
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