Clinical trial: NCT02337465
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks

We do not anticipate any discomfort or medical risks to you if you decide to participate in this research. There is a possibility, however, of a loss of confidentiality. We will take steps to protect your personal information by the following methods: (a) only the research members will have access to your file and all members of our research team will be bound by rules of confidentiality not to reveal your identity to others; (b) we will keep our research results in a locked office and stored in a password protected computer; (c) we will publish or report our results without the identities of individuals.
Clinical trial: NCT02337465
Section: Procedures
Subsections: About 30 People Will Take Part In This Research Study. Study Procedures

As a participant in this study, you will go through many routine clinical procedures of radiotherapy, including initial consultation, simulation, treatment verification, and a course of dily treatment, which may last one week to seven weeks, depending on your specific treatment prescription.  
As a participant in this study, during simulation procedure, you will be asked to acquire additional ultrasound study to identify the location of tumor in addition to the routine CAT scan.  
The cost of this research ultrasound study will not be charged to you or your insurance. During your daily treatment, in addition to your routine CAT for position verification, additional ultrasound study will be performed to localize the tumor prior to each treatment. If the ultrasound probe is identified not to block your radiation beams during simulation study, the ultrasound probe will be attached to your body held by the FISSIO holding arm during treatment to further monitor the tumor motion.  
There are no additional visits involved to participate in this study. During your routine simulation, the added ultrasound study may prolong your simulation for 10 minutes.  During routine pre-treatment imaging verification, the added ultrasound study may prolong your setup for 5 minutes.
Clinical trial: NCT02337465
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this research study is voluntary.  Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.  If information generated from this study is published or presented, your identity will not be revealed.  
In the event new information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Clinical trial: NCT02337465
Section: Withdrawal from Study
Subsections: Termination Of Participation

Your participation in this study may be discontinued by the sponsor (NIH) or investigator without your consent if we find that your tumor cannot be localized by the ultrasound images.