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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04110249
• Other study ID #: I 48917
• Secondary ID: NCI-2019-06045I
• Status: Terminated
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: December 29, 2022

Study information

• Verified date: April 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Carcinoma
• Head and Neck Lymph Node
• Head and Neck Squamous Cell Carcinoma
• Laryngeal Neoplasm
• Laryngeal Neoplasms
• Radiation Therapy Recipient
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Photoacoustic Imaging
Undergo PAI
• Transcutaneous Acupoint Electrical Stimulation
Undergo ALTENS

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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