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

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ClinicalTrials.gov Identifier: NCT04110249
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 25, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE September 24, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 25, 2021
Actual Study Start Date  ICMJE September 6, 2019
Estimated Primary Completion Date September 6, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • 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
  • Changes in hemoglobin (hbt) measurements [ Time Frame: Up to 2 years ]
    Compare hemoglobin measurements between baseline until end of study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer
Official Title  ICMJE A Pilot Study of Photoacoustic Imaging (PAI) in H&Amp;N Cancer Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Head and Neck Carcinoma
  • Head and Neck Lymph Node
  • Head and Neck Squamous Cell Carcinoma
  • Laryngeal Neoplasm
  • Radiation Therapy Recipient
Intervention  ICMJE
  • Procedure: Photoacoustic Imaging
    Undergo PAI
  • Procedure: Transcutaneous Acupoint Electrical Stimulation
    Undergo ALTENS
    Other Names:
    • acupuncture-like transcutaneous electrical nerve stimulation
    • ALTENS
    • TAES
Study Arms  ICMJE 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.

Interventions:
  • Procedure: Photoacoustic Imaging
  • Procedure: Transcutaneous Acupoint Electrical Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2021)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2019)
48
Estimated Study Completion Date  ICMJE September 6, 2025
Estimated Primary Completion Date September 6, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04110249
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Anurag K Singh Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP