NCT04428515 Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 50 participants in total. It began in 2019-04-23 with a primary completion date of 2024-04-23.

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.

Eligibility Criteria

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

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