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

A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Radiation Therapy Recipient; Head and Neck Lymph Node; Laryngeal Neoplasm
• Intervention / Treatment: Procedure: Photoacoustic Imaging; Procedure: Transcutaneous Acupoint Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (PAI, ALTENS); 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.

Procedure: Photoacoustic Imaging; Undergo PAI; Procedure: Transcutaneous Acupoint Electrical Stimulation; Undergo ALTENS; Other Names: acupuncture-like transcutaneous electrical nerve stimulation; ALTENS; TAES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in hemoglobin (hbt) measurements	Compare hemoglobin measurements between baseline until end of study	Up to 2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): December 29, 2022

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Carcinoma, Squamous Cell; Laryngeal Diseases; Carcinoma; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms
• Other Study ID Numbers: I 48917 (Other Identifier: Roswell Park Cancer Institute); P30CA016056 (U.S. NIH Grant/Contract); NCI-2019-06045 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA204636 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No