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

Roswell Park Comprehensive Cancer Center

Status: Terminated

Conditions: Radiation Therapy Recipient; Head and Neck Lymph Node; Head and Neck Carcinoma; Laryngeal Neoplasm; Head and Neck Squamous Cell Carcinoma

Treatments: Procedure: Transcutaneous Acupoint Electrical Stimulation; Procedure: Photoacoustic Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04110249

P30CA016056 (U.S. NIH Grant/Contract)

I 48917 (Other Identifier)

R01CA204636 (U.S. NIH Grant/Contract)

NCI-2019-06045 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Diagnostic (PAI, ALTENS)

Experimental group

Description:

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.

Treatment:

Procedure: Photoacoustic Imaging

Procedure: Transcutaneous Acupoint Electrical Stimulation