Patients must be able to understand and provide written informed consent Able to understand the nature of this trial and provide written informed consent Able to understand the investigational nature of this study and to provide written consent to participate in it Male or female ? 18 years of age. 4. Weigh ? 35 kg. 5. ECOG performance score 0-2, inclusively. 6. Negative ?-hCG test in women of childbearing potential. 7. Able to understand and comply with the requirements of the study and to provide written informed consent. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients. Patients must be able to understand and provide written informed consent PART I: Able to understand and provide informed consent PART II: Able to understand and provide informed consent Able to understand and give written informed consent Patients are able to understand and provide written informed consent prior to trial participation Patients must be willing and able to review, understand, and provide written consent before study enrollment Female or male patients, >18 years of age, able to understand and give written informed consent. Patients must be willing and able to review, understand, and provide written consent before study enrollment Patients must be willing and able to review, understand, and provide written consent before starting therapy Patients must be willing and able to review, understand, and provide written consent before starting therapy Able to understand and willing to provide written informed consent. Male or female patients, ? 18 years of age, able to understand and give written informed consent. Able to understand and provide informed consent Male or female patients, ? 18 years of age, able to understand and give written informed consent Participants must be willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy. Patients must be willing and able to review, understand, and provide written consent before starting therapy Patients willing and able to review, understand, and provide written consent before starting therapy Patients must be willing and able to review, understand, and provide written consent before starting therapy Able to understand and have the ability to provide written consent Able to understand and provide written informed consent Able to understand and provide written informed consent Patients able to understand the nature of the study and who are willing to give written informed consent; Patients must be willing and able to review, understand, and provide written consent Patients willing and able to review, understand, and provide written consent Patients willing and able to review, understand, and provide written consent before starting therapy Patients who are willing and able to review, understand, and provide written consent Able to understand and willing to provide informed consent for the RPFNA’s and study participation Understand the study procedures and able to provide informed consent Able to read or understand and provide informed consent Able to understand the experimental nature of the study and provide informed consent Participants who are not able to understand or provide written informed consent