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

Primary Purpose

Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photoacoustic Imaging
Transcutaneous Acupoint Electrical Stimulation
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (PAI, ALTENS)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Utility of serial PAI-based oxygen saturation (%sO2) measurements
Descriptive statistics (means, medium) will be used to summarize percent of SO2
Changes in hemoglobin (hbt) measurements
Compare hemoglobin measurements between baseline until end of study

Full Information

First Posted
September 24, 2019
Last Updated
April 7, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04110249
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
equipment issues
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
December 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma, Head and Neck Lymph Node, Head and Neck Squamous Cell Carcinoma, Laryngeal Neoplasm, Radiation Therapy Recipient

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (PAI, ALTENS)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Photoacoustic Imaging
Intervention Description
Undergo PAI
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Acupoint Electrical Stimulation
Other Intervention Name(s)
acupuncture-like transcutaneous electrical nerve stimulation, ALTENS, TAES
Intervention Description
Undergo ALTENS
Primary Outcome Measure Information:
Title
Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate
Description
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Time Frame
Up to 6 months after treatment completion
Title
Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate
Description
Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Utility of serial PAI-based oxygen saturation (%sO2) measurements
Description
Descriptive statistics (means, medium) will be used to summarize percent of SO2
Time Frame
Up to 2 years
Title
Changes in hemoglobin (hbt) measurements
Description
Compare hemoglobin measurements between baseline until end of study
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag K Singh
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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