Actively Recruiting

All Genders
NCT04428515

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

Led by Sunnybrook Health Sciences Centre · Updated on 2023-12-13

50

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed head and neck carcinoma not previously treated with first-line therapy and planned for radiotherapy
  • Measurable disease by ultrasound or MRI 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 shown by laboratory tests 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/ALT less than 2.5 times institutional upper limit
    7. Creatinine within normal limits or creatinine clearance >60 mL/min/1.73 m2 if above normal
  • Able to give written informed consent
  • Willing and able to follow safety procedures during scanning period
Not Eligible

You will not qualify if you...

  • Chemotherapy, radiotherapy, or major surgery within 4 weeks before study registration or not recovered from prior adverse events
  • Receiving other investigational agents
  • Known brain metastases
  • History of allergic reactions to similar compounds
  • Contraindications to radiotherapy, including previous radiotherapy to involved area, active collagen vascular disease, or genetic diseases causing hyper-radiosensitivity
  • Serious infections requiring systemic antibacterial, antifungal, or antiviral treatment
  • Uncontrolled illness such as ongoing infection
  • Symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
  • History of active seizure disorder
  • Any unstable condition that could risk patient safety or study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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