Clinical trial: NCT03109262
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?

Participant ID:
You should not feel obligated to agree to participate. Your questions should be answered clearly and to your satisfaction. If you decide not to participate, tell the Protocol Director, Dr. Andrei Iagaru. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. However, there is always some risk that even de-identified information might be re-identified. Patient information may be provided to Federal and other regulatory agencies as required. The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.  
  
  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT

Because information about you and your health is personal and private, it generally cannot be used in this research study without your written authorization. If you sign this form, it will provide that authorization. The form is intended to inform you about how your health information will be used or disclosed in the study. Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law. Please read it carefully before signing it.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
The Protocol Director, Dr. Andrei Iagaru The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research Staff Participant ID:
research). If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to:
Dr. Andrei Iagaru, Protocol Director Stanford Radiology, Division of Nuclear Medicine and Molecular Imaging

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study:
The Office for Human Research Protections in the U.S.  
Department of Health and Human Services GE Healthcare The Food and Drug Administration Your Referring Physician Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.  
IRB Use Only  
  
Approval Date: January 15, 2019 Expiration Date: January 15, 2020  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT
Participant ID:
When will my authorization expire?  
Your authorization for the use and/or disclosure of your health information will end on December 31, 2030, or when the research project ends, whichever is earlier.  
________________________________ ______________ Signature of Adult Participant Date ________________________________
Print Name of Adult Participant
_____________________________ ______________ Signature of Legally Authorized Representative (LAR) Date
(e.g., parent, guardian or conservator)
________________________________ Print Name of LAR __________________________________________________
LAR's Authority to Act for Participant (e.g., parent, guardian or conservator)  
  
IRB Use Only Approval Date: January 15, 2019 Expiration Date: January 15, 2020  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT
Clinical trial: NCT03109262
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:
Follow the instructions of the Protocol Director and study staff.  
Undergo the digital PET/CT scan as instructed  
  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT  
Tell the Protocol Director or research study staff about any side effects, doctor visits, or hospitalizations that you may have.  
Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
Ask questions as you think of them.  
Tell the Protocol Director or research staff if you change your mind about staying in the study.
Clinical trial: NCT03109262
Section: Participant's Rights
Subsections: Participant'S Rights

Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT
You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.
Clinical trial: NCT03109262
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, Discomforts, And Inconveniences

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. You should talk with the Protocol Director if you have any questions.  
Patients who are claustrophobic may feel some anxiety while positioned in the scanner;  
  
  
  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT
Some patients find it uncomfortable to hold one position for more than a few minutes; As a participant, you will receive exposure to radiation from the CT
portion of the PET/CT scan, that is not necessary for your medical care and is for research purposes only. The additional amount of radiation exposure is up to approximately 5.0 mSv, which is approximately equal to 10% of the limit that radiation workers (for example, a hospital x-ray technician) are allowed to receive in one year. This amount of radiation involves minimal risk and is neessary to obtain the research information desired.  
If you are pregnant or breast-feeding, you may not particiapte in this study.  
here is a small volume (50 ml) of iodinated contrast to be given during the CT scan. This will require the introduction of an intravenous (IV) catheter. As with any IV catheter, there is some discomfort associated with introduction of the catheter. There can also be some redness and swelling associated with the catheter placement, but these will usually subside quickly. With the contrast injection, there is a risk of contrast extravasation (leakage) into the skin which can cause swelling and mild pain. You will be offered a hot or cold compress to help mobilize any extravasated contrast, and if very severe, you would be offered the appropriate supportive care, which in rare instances includes transfer to the emergency room and surgical consultation.  
If you have had a pervious reaction to iodinated contrast agents or a history of severe allergies, (e.g., to medications, iodine, contast agents, tap, latex, bee-sting, food, shellfish, nuts), please notify study team and scan operator.  
If there is any reason for you not to have the iodinated contrast, it will be omitted at physician discretion.
Clinical trial: NCT03109262
Section: Procedures
Subsections: Procedures

After you have had the SIRT procedure, the research portion of the study will begin. You arrive to Nuclear Medicine for your research scan.  
You will be asked to lie still on the padded table during the scan because movement can interfere with the results.  
You will be asked to breathe normally during both the CT and the PET
portion of the scan.  
  
  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT  
Nuclear Medicine technologists will administer contrast during the CT scan to help show tumor morphology on the scan.  
The table will move slowly through the tube-shaped digital PET/CT
scanner for 30 minutes while images are acquired.  
Our technologist will monitor you throughout the duration of the scan.  
The scan should take approximately 30-minutes.  
You will only undergo one (1) digital PET/CT scan. After this scan, the research part of the study is over.
Depending on the timing of your SIRT procedure, your schedule, as well as the Nuclear Medicine staff, you may receive your post-SIRT procedure research scan the same day, or the day after your SIRT therapy. If your imaging is happening on the same day, the IR nurses will leave your IV in to be used by Nuclear Medicine to give the CT contrast. After imaging is over, the IV will be removed. If your imaging is happening the next day, then IR will remove the IV before sending you home. A new IV will be placed for the CT contrast material the next day. After imaging is over, the IV will be removed. If you a have an iodinated contrast allergy, the contrast injection will be omitted.
Clinical trial: NCT03109262
Section: Purpose of Research
Subsections: Purpose Of Research|What Is The Purpose Of This Research Study And How Will My Health Information Be Utilized In The Study?

Participant ID:
Are you participating in any other research studies? _____ Yes _____No You are invited to participate in a research study of evaluating the image quality and feasibility of digital PET/CT imaging after selective internal radiation therapy (SIRT). We hope to learn if the images produced by the digital PET/CT scanner can provide superior information about the distribution of the particles delivered for SIRT compared to the 99mTc-MAA SPECT/CT images. You were selected as a possible participant in this study because your doctors referred you to the Nuclear Medicine and Interventional Radiology Clinics for evaluation of extent of disease and you are scheduled to undergo SIRT. After you undergo SIRT, we would like you to have a digital PET/CT scan; the digital PET/CT scan is the research portion of the study. If you decide to terminate your participation in this study, you should notify Dr. Andrei Iagaru, the Protocol Director, Stanford University expects to enroll up to 75 research study participants.

The purpose of this research is to assess the image quality of the digital PET/CT scanner. The Protocol Director, research team, and the sponsor, and other regulatory agencies as required will have access to the results. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. Your identity and/or your personal health information will not be disclosed except as authorized by you or as required by law. Do I have to sign this authorization form?  
You do not have to sign this authorization form. But if you do not, you will not be able to participate in this research study.  
Signing the form is not a condition for receiving any medical care outside the study. If I sign, can I revoke it or withdraw from the research later?  
If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time. After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of Page 6 of 12  
  
Protocol Title: High quality imaging and dosimetry of Yttrium-90 (90Y) SIRT using a digital PET/CT
What Personal Information Will Be Obtained, Used or Disclosed?  
Your health information related to this study, may be used or disclosed in connection with this research study, including your name, MRN, age, gender, medical condition; and your 99mTc-MAA SPECT/CT and 90Y digital PET/CT images.
Clinical trial: NCT03109262
Section: Voluntary Participation
Subsections: Voluntary Participation

Your participation in this study is entirely voluntary. Your decision not to participate will not have any negative effect on you or your medical care. You can decide to participate now, but withdraw your consent later and stop being in the study without any loss of benefits or medical care to which you are entitled.
Clinical trial: NCT03109262
Section: Withdrawal from Study
Subsections: Withdrawal From Study

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time. Your decision will not affect your ability to receive medical care for your disease and you will not lose any benefits to which you would otherwise be entitled. If you decide to withdraw your consent to participate in this study, you should notify Dr. Andrei Iagaru, the Protocol Director, at . If you withdraw from the study your images will not be analyzed or used in the research study. The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
Failure to follow the instructions of the Protocol Director and study staff.  
The Protocol Director decides that continuing your participation could be harmful to you.  
Pregnancy You need treatment not allowed in the study.  
The study is cancelled.  
Other administrative reasons.  
Unanticipated circumstances.