Status:
RECRUITING
Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
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 object...
Detailed Description
A trained clinical research coordinator will evaluate and authorize that each screened volunteer is a suitable subject for the study prior to enrolment. Written informed consent will be obtained from ...
Eligibility Criteria
Inclusion
- 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:
- hemoglobin \>90 mg/dL
- leukocytes \>3,000/mL
- absolute neutrophil count \>1,500/mL
- platelets \>100,000/mL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
- 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
- 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:
- previous radiotherapy to an involved area
- active collagen vascular disease
- 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
Key Trial Info
Start Date :
April 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 23 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04428515
Start Date
April 23 2019
End Date
April 23 2027
Last Update
December 13 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5