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

NCT04110249 | Terminated

• 4 other identifiers: I 48917NCI-2019-06045P30CA016056R01CA204636
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Utility of serial PAI-based oxygen saturation (%sO2) measurements

  Up to 2 years

• Changes in hemoglobin (hbt) measurements

  Up to 2 years

Study Arms (1)

Diagnostic (PAI, ALTENS)

EXPERIMENTAL

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; Procedure: Transcutaneous Acupoint Electrical Stimulation

Interventions

Photoacoustic Imaging PROCEDURE

Undergo PAI

Diagnostic (PAI, ALTENS)

Transcutaneous Acupoint Electrical Stimulation PROCEDURE

Undergo ALTENS

Also known as: acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAES

Diagnostic (PAI, ALTENS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Officials

• Anurag K Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 1, 2019
• Study Start: September 6, 2019
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

US (1)