Recruiting

Photoacoustic Imaging

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04428515

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Photoacoustic Imaging System

Study Details

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.

Conditions

Head and Neck Cancer

Study ID

NCT04428515

Start date

Apr 23, 2019

Status verified date

Dec, 2023

Completion date

Apr 23, 2027

Anticipated

Primary completion date

Apr 23, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Radiotherapy Response Monitoring

Those undergoing radiation therapy treatment to their lymph nodes upon diagnosis of head and neck cancer

Interventions

Photoacoustic Imaging System

Photoacoustic Imaging 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

Primary outcome measure

  • Correlation of response to treatment between photoacoustic parameters and final radiological outcome. measures of outcome. [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 13, 2023

Last verified

Dec, 2023

Keywords

  • Photoacoustic
  • Head and Neck
  • Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-12-13.