Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

STATUS

Recruiting
participants needed

50
sponsor

Sunnybrook Health Sciences Centre

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Updated on 19 February 2024

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cancer

measurable disease

neutrophil count

chemoradiotherapy

carcinoma

head and neck cancer

renal function test

neck cancer

head and neck carcinoma

chemoradiation therapy

photoacoustic imaging

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.

Details

Condition	head and neck cancer, head and neck cancer
Age	100years or below
Clinical Study Identifier	NCT04428515
Sponsor	Sunnybrook Health Sciences Centre
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	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 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
	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

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Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer