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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110249
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Head and Neck Carcinoma Head and Neck Lymph Node Head and Neck Squamous Cell Carcinoma Laryngeal Neoplasm Radiation Therapy Recipient Procedure: Photoacoustic Imaging Procedure: Transcutaneous Acupoint Electrical Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : July 13, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Feasibility of photoacoustic imaging (PAI) to quantify tumor characteristics (part I): rate [ Time Frame: Up to 6 months after treatment completion ]
    Feasibility rate is defined as the proportion of evaluable patients who have at least 3 imaging sessions that produce a usable image.

  2. Feasibility of PAI to quantify tumor characteristic in patients undergoing ALTENS (part II): rate [ Time Frame: Up to 2 years ]
    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 :
  1. Utility of serial PAI-based oxygen saturation (%sO2) measurements [ Time Frame: Up to 2 years ]
    Descriptive statistics (means, medium) will be used to summarize percent of SO2

  2. Changes in hemoglobin (hbt) measurements [ Time Frame: Up to 2 years ]
    Compare hemoglobin measurements between baseline until end of study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No restriction on race or ethnic background
  • Subject or legal representative 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110249


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Anurag K. Singh    716-845-3175    Anurag.Singh@roswellpark.org   
Principal Investigator: Anurag K. Singh         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anurag K Singh Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04110249    
Other Study ID Numbers: I 48917
NCI-2019-06045 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 48917 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
R01CA204636 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Carcinoma
Squamous Cell Carcinoma of Head and Neck
Laryngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases