Pilot Study to Evaluate Photoacoustic Imaging in Head and Neck Cancer

Korábbi kezelés

• 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
• 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

Más betegség

• History of allergic reactions attributed to compounds of similar chemical or biologic composition
• 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

Egyéb

• Known brain metastases

• 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;