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Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04428515
Collaborator
(none)
50
Enrollment
1
Location
60
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, PA imaging will be used to examine the physiological and physical changes in lymph node involvements of head and neck cancer during radiotherapy with or without chemotherapy. Our objective in this pilot study will be to evaluate if PA parameters change within the lymph node involvements during chemoradiation therapy over time. Our hope is to use this information to correlate the changes in measured PA parameters with radiological response.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
    Actual Study Start Date :
    Apr 23, 2019
    Anticipated Primary Completion Date :
    Apr 23, 2022
    Anticipated Study Completion Date :
    Apr 23, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Radiotherapy Response Monitoring

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome. [3 months]

      The primary study endpoint will investigate changes of measured PA markers and compare these to radiological assessment of response of lymph node involvement to chemoradiation therapy for head and neck cancer. Changes in PA parameters will be made to a pre-treatment point over the course of treatment.

    Secondary Outcome Measures

    1. Correlation between photoacoustic parameters and five-year overall survival. [5 years]

      The secondary study endpoint will correlate changes of measured PA markers to five-year overall survival (OS) of the same patient cohort. The survival status and of the patient cohort will be tracked after the treatment for five years based on the patient information system and follow up surveys if necessary.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Histologically or cytologically confirmed head and neck carcinoma which has not been treated with any first-line therapy and will be treated with radiotherapy

    • Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment

    • Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1

    • Life expectancy of at least 6 months

    • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:

    1. hemoglobin >90 mg/dL

    2. leukocytes >3,000/mL

    3. absolute neutrophil count >1,500/mL

    4. platelets >100,000/mL

    5. total bilirubin within normal institutional limits

    6. AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

    7. creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal

    • Subjects must give appropriate written informed consent prior to participation in the study;

    • Subjects must be able and willing to comply with the safety procedures during the Scanning Period;

    Exclusion Criteria:

    • Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration

    • Receiving any other investigational agents

    • Known brain metastases

    • History of allergic reactions attributed to compounds of similar chemical or biologic composition

    • Contraindications to radiotherapy such as but not limited to:

    1. previous radiotherapy to an involved area

    2. active collagen vascular disease

    3. genetic diseases associated with hyper-radiosensitivity

    • Any clinically serious infections requiring systemic anti-bacterial, antifungal or antiviral therapy

    • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection,

    • Symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia

    • History of active ongoing seizure disorder

    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Gregory J Czarnota, PhD, MD, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Gregory Czarnota, Senior Scientist, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT04428515
    Other Study ID Numbers:
    • 135-2018
    First Posted:
    Jun 11, 2020
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Gregory Czarnota, Senior Scientist, Sunnybrook Health Sciences Centre
    Photoacoustic
    Head and Neck
    Radiotherapy
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Jun 11, 2020