Clinical trial NCT04110249: Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
Official title: A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Carcinoma
Head and Neck Lymph Node
Head and Neck Squamous Cell Carcinoma
Laryngeal Neoplasm
Radiation Therapy Recipient
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
timeFrame: Up to 6 months after treatment completion
measure: Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Utility of serial PAI-based oxygen saturation (%sO2) measurements
timeFrame: Up to 2 years
measure: Changes in hemoglobin (hbt) measurements
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: