Clinical trial: NCT02088775
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Choices Do You Have If You Do Not Take Part In This Research Study?

Taking part in this study may not make your health better. We do know that the information from this study will help doctors learn more about radioembolization as a treatment for cancer. This information could help future cancer patients.

Your other choices may include: Getting treatment or care for your cancer without being in a study Taking part in another study Getting no treatment Talk to your doctor about your choices before you decide if you will take part in this study.
Clinical trial: NCT02088775
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
Site name and IRB Fox Chase Cancer Center The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), involved in keeping research safe for people
A description of this clinical trial will be available on *http://www.ClinicalTrials.gov*, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. You will be given a separate form to review regarding the steps we will take to guard your privacy as part of your participation in the research study. By signing that additional authorization, you will be providing your consent to use and disclose information described in that form connected with your participation in this research study.
Clinical trial: NCT02088775
Section: Duration of Study Involvement
Subsections: Visit 1|Follow-Up

Visit 1 will take place after the pretreatment visits, and will be referred to as Day 0, the day of radioembolization. Visit 1 will include the following procedures:
- PET/CT is an imaging technology that combines two imaging modalities
(PET and CT images) into one image  
o PET stands for "positron emission tomography," and CT stands for "computed tomography." This combination allows doctors to see the location and function of cells within the body o A PET scan produces 3-D images to see how your cells work.  
It requires an injection of a radioactive material into a vein. Pictures will be taken of your body with a special donut shaped camera as you lie very still on a table o A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body as you lie on the same table that moves slowly through the donut shaped camera
- Radioembolization - This will be the injection of the treatment dose of radioactive spheres to treat your liver cancer.  
- PET-CT performed just after the radioembolization in order to measure radioembolization dose.

Follow-up visits will occur after treatment and will be scheduled at 1 week, 1 month, and then every 3 months for one year, every 6 months for 1 year and then annually for 3 years or until local disease progression or death. Study follow-up visits may be with any investigator.
Clinical trial: NCT02088775
Section: Participant's Rights
Subsections: What Are Your Rights If You Take Part In This Research Study?

Taking part in this research study is your choice. You may choose either to take part or not to take part in the research study. If you decide to take part in this study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT02088775
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Risks Can You Expect From Being In The Research Study?|Radiation Risk For Diagnostic Imaging|Reproductive Risks

You may have side effects while on the research study. Everyone taking part in the research study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. In some cases, side effects can be serious, long lasting, or may never go away. You should talk to your study doctor about any side effects that you have while taking part in the research study.

It is unlikely that there will be any harmful effects from the radiation exposure you will receive from participating in this study.  
At high levels of exposure, scientists agree that radiation can cause cancer.  
At low exposure levels most scientists agree that the risk, if any, is very low. You will have low levels of radiation exposure with diagnostic imaging procedures.  
Blood Draw Risks Fainting Bleeding Bruising at the place on your arm where the blood was drawn or needle inserted Pain Swelling Infection (rare)

Radiation treatments may make you sterile (unable to have children).  
This study may affect a baby, before or after the baby is born.  
You should not become pregnant or father a baby while on this research study because the procedures in this study could possibly hurt an unborn baby.  
If you are pregnant now or if you are breast-feeding now, you may not take part in this research study.  
If you become pregnant while you are on the research study, you may not continue to take part in the research study.  
For women who can become pregnant:
You should not become pregnant while you are in this study.  
You should not breast-feed your baby while taking drugs for this research study.
Clinical trial: NCT02088775
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study?|Blood Tests|Pretreatment

Before you begin the research study… You will need to have the following exams, tests or procedures to find out if you can be in the research study. These exams, tests or procedures are part of regular cancer care and may be done even if you do not join the research study. If you have had some of them recently, they may not need to be repeated. This will be up to your study doctor.

5 ml (cc) = 1 teaspoon, 10 ml = 2 teaspoons
- Blood counts: purple top tube (5 ml or about 1 teaspoon)
- Blood pregnancy (10ml or about 2 teaspoons), if you are a woman of child bearing potential.  
- Chemistry: red top tube (10 ml or about 2 teaspoons) - Coagulation studies: blue top tube (3 ml or about ½ teaspoon)
IMAGING EXAMS
- A CT scan is a computerized x-ray that gives your study doctor pictures of the inside of your body
- A MRI scan uses a magnetic field and radio waves to take pictures of the inside of your body
During the research study…
You will need to have the following exams, tests or procedures. These exams, tests or procedures may be a part of regular cancer care and may be done even if you do not join the research study.

Staging Angiogram - A mapping of the blood vessels going to your liver in order to ensure that the radioactive spheres will be injected only to the region of the liver containing your cancer.  
Coil Embolization - Any blood vessels leading away from the liver toward a region that should not receive radiation will be clogged off using coil embolization. This will prevent radioactive spheres from being delivered to unintended areas such as small intestine or stomach.  
Tc-99m test injection - A tiny test dose of radiation will be delivered at the end of the staging angiogram in order to ensure that the amount of radiation exposure to the lungs is safe. SPECT scan: A SPECT Scan is a single-photon emission computerized tomography (SPECT) scan lets your doctor analyze the function of some of your internal organs. A SPECT scan is a type of nuclear imaging test, which means it uses a radioactive substance and a special camera to create 3-D pictures. A 3 Phase Liver CT simulation must before Day 0 (Treatment Initiation Day). This simulation may occur before or after the staging angiogram, coil embolization, Tc99m test injection, and planar and SPECT imaging of the participant's liver.  
You will receive radioembolization in this research study. The radioembolization is standard of care treatment. You may need a second treatment with radioembolization, this will be up to your study doctor. The visits discussed below refer to your first radioembolization treatment only. You will need to repeat these tests or procedures if you are going to have a second embolization.
Clinical trial: NCT02088775
Section: Purpose of Research
Subsections: Why Is This Research Study Being Done?

The purpose of this research study is to determine the relationship if any, between the radiation dose delivered with radioembolization to 70% of the total amount of your liver disease, which will be determined by an after-treatment PET-CT, and local control of your liver disease at 6 months. We do not expect you will benefit from this research study. We can use what we learn from this research study to help other people with the same disease.
Clinical trial: NCT02088775
Section: Withdrawal from Study
Subsections: Can You Stop Being In The Research Study?|Can You Be Removed From This Research Study?

Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. It is important to tell the study doctor if you are thinking about stopping to discuss what followup care and testing could be most helpful for you.

The study doctor may stop you from taking part in this research study at any time if he/she believes it is in your best interest; if you do not follow the research study rules; or if the research study is stopped.