Clinical trial: NCT00375830
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Used Or Disclosed?

Your identity will be kept as confidential as possible, as required by law. Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier.  
The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed. 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.

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.

Your health information related to this study may be used or disclosed in connection with this research study, including, but not limited to, your name, contact information and medical record number, date of birth, medical history, physical examination, lab tests, pathology, and imaging tests such as x-rays, CT scans, bone scans, and ultrasounds studies.  
Who May Use or **Disclose the Information?**
The following parties are authorized to use and/or disclose your health information in connection with this research study:
Dr. Andrei Iagaru (the Protocol Director) and members of the research team including technicians and research coordinators.  
The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary.  
Who May Receive / Use the Information?  
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 This research is being conducted in part with support from GE Healthcare.  
Personal information (such as name or date of birth) will not be used in the information or the images being shared with GE Healthcare. Anonymized images will be provided to GE Healthcare for product development and quality assurance purposes. The provided information will also be used to improve instruments.  
The Food and Drug Administration
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.
Clinical trial: NCT00375830
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

The accrual period will be approximately 2 years for the next 50 participants. Your participation in this study is expected to last approximately 2 hours for the PET/MRI visit. Clinical follow-up will be 12 months after the scan. Data analysis will require up to 6 months.  
Protocol Title: Combined 18F NaF/18**F FDG PET/MRI for Detection of Skeletal Metastases**
Clinical trial: NCT00375830
Section: Participant Responsibilities
Subsections: Subject'S Responsibilities

You should:
Ask questions as you think of them.  
Tell the Protocol Director or research staff if you change your mind about staying in the study.
While participating in this study, you should not take part in any other research project without approval from all of the investigators. This is to protect you from possible injury arising from such things as extra blood drawing, extra x-rays, interaction of research drugs, or similar hazards.
Clinical trial: NCT00375830
Section: Participant's Rights
Subsections: Subject'S Rights|Experimental Subject'S Bill Of Rights

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. You will still receive care for your disease and will not lose any benefits to which you would otherwise be entitled. 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.

As a human subject you have the following rights. These rights include but are not limited to the subject's right to:  
be informed of the nature and purpose of the experiment; be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; be given a description of any attendant discomforts and risks reasonably to be expected; be given an explanation of any benefits to the subject reasonably to be expected, if applicable; be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should rise; be given an opportunity to ask questions concerning the experiment or the procedures involved; be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the subject's decision.
Signing your name means you agree to be in this study and that you were given a copy of this signed and dated consent form. _________________________________________ ___________________  
 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) _____________________________________ ____________ (If available) Signature of Other Parent or Guardian Date  
  
Protocol Title: Combined 18F NaF/18**F FDG PET/MRI for Detection of Skeletal Metastases**  
 _____________________________________
Print Name of Other Parent or Guardian
_____________________________________ Authority to Act for Participant _____________________________________ ____________ Signature of Person Obtaining Consent Date _____________________________________ Print Name of Person Obtaining Consent The following witness line is to be signed only if the consent is provided as a summary form and accompanied by a short form foreign language consent. _____________________________________ ____________ Signature of Witness Date __________________________________ Print Name of Witness (e.g., staff, translator/interpreter, family member, or other person who speaks both English and the participant's language)  
*Translated short form must be signed and dated by both the participant (or their LAR) AND*
the witness.  
*The English consent form (referred to as the "Summary Form" in the regulations):*
*Must be signed by the witness AND the Person Obtaining Consent (POC).* *The non-English speaking participant/LAR does not sign the English consent.* *The non-English speaking participant/LAR should not sign the HIPAA participant line* *If the participant or the LAR is non-English speaking, the Person Obtaining Consent (POC)*
must ensure that 1) the LAR's Description of Authority is completed and 2) that any questions or options presented by the consent form are documented and initialed by the POC on the Summary Form, per the participant's wishes, as they are understood during the consent process.
Clinical trial: NCT00375830
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks Of Mri:|Possible Risks, Discomforts, And Inconveniences

Magnetic fields do not cause harmful effects at the levels used in the MRI machine. However, the MR scanner uses a very strong magnet that will attract some metals and affect some electronic devices. If you have a cardiac pacemaker or any other biomedical device in or on your body, it is very important that you tell the operator/investigator immediately. As metallic objects may experience a strong attraction to the magnet, it is also very important that you notify the operator of any metal objects (especially surgical clips), devices, or implants that are in or on your body before entering the magnet room. All such objects must be removed (if possible) before entering the magnet room. In some cases, having those devices means you should not have an MRI scan performed. In addition, watches and credit cards should also be removed as these could be damaged. You will be provided a way to secure these items. If you have any history of head or eye injury involving metal fragments, if you have ever worked in a metal shop, or if you could be pregnant, you should notify the operator/investigator. There is a possibility that you will experience a localized twitching sensation due to the magnetic field changes during the scan. This is expected and should not be painful. If you have had a previous reaction to Gadolinium-based contrast agents, a history of severe allergies, or a history of kidney disease, please notify the operator/investigator. Some of the hardware, imaging software and devices being used in your scan are not approved by the FDA, but are similar to counterparts that have been approved by the FDA. There is a small risk of heating from the cables associated with these devices. Please report any heating sensation immediately. IF YOU FEEL DISCOMFORT AT ANY TIME, NOTIFY THE OPERATOR AND YOU CAN DISCONTINUE THE EXAM AT ANYTIME.  
  
The scans performed in this study are for specific research purposes and are not optimized to find medical abnormalities. The investigators for this project may not be trained to perform medical diagnosis. The investigators and Stanford are not responsible for failure to find existing abnormalities with these MRI scans. However, on occasion the investigator may notice a finding on an MRI scan that seems abnormal. When this occurs, a physician will be consulted as to whether the findings merits further investigation, in which case the investigator will contact you and your primary care physician and inform you of the finding. The decision as to whether to proceed with further examination or treatment lies solely with you and your physician. The investigators, the consulting physician, and Stanford are not responsible for any examination or treatment that you undertake based on these findings. Because the images collected in this study may not comprise a proper clinical MRI scan, these images will not be made available for diagnostic purposes. Dizziness and nausea may occur if the head is moved rapidly within the bore of the magnet.

There are risks, discomforts, and inconveniences associated with any research study. These deserve careful thought. The administration of the radioactive substance for the PET/MRI will feel like a slight pinprick if given by intravenous injection. Patients who are claustrophobic may feel some anxiety while positioned in the scanner. Also, some patients find it uncomfortable to hold one position for more than a few minutes. You will not feel anything related to the radioactivity of the substance in your body. Because the radioactivity is very short-lived, the radiation exposure is low. The substance amount is so small that it does not affect the normal processes of the body. This research study involves exposure to radiation from one 18F Sodium Fluoride combined with 18F FDG PET study. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation exposure is about 540 mrem, which is approximately equal to 11% of the limit that radiation workers are allowed to receive in one year. This amount of radiation involves minimal risk and is necessary to obtain the research information desired. Side effects of the MRI contrast agent injection include mild headache, nausea and local pain. Rarely (less than 1% of the time) low blood pressure and lightheadedness occurs. This can be treated immediately with intravenous fluids. Very rarely (less than one in one thousand), patients are allergic to the contrast agent. These effects are most commonly hives and itchy eyes, but more severe reactions have been seen which result in shortness of breath. If you have had a previous reaction to Gadolinium-based contrast agents or a history of severe allergies, please notify the operator/investigator. PET/MRI may involve risks to the subject (or the embryo, fetus, or nursing infant if the subject is or may become pregnant) which are currently unforeseeable.  
  
If you are a woman who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast feeding, you may not participate in this study. You understand that if you are pregnant, if you become pregnant, or if you are breastfeeding during this study, you or your child may be exposed to an unknown risk.  
To confirm to the extent medically possible that you are not pregnant, you agree to have a pregnancy test done before beginning this research study. You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the investigator and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of reliable method of birth control. You agree to notify the investigator as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study. You should talk with the Protocol Director if you have any questions.
Clinical trial: NCT00375830
Section: Procedures
Subsections: Procedures

If you choose to participate, Dr. Iagaru and his research study staff will set up your PET/MRI examination. You will lie on a comfortable padded table. A glucose (sugar) solution containing a small amount of radioactivity (named FDG) and F-18 sodium fluoride (NaF, a chemical that binds to bony structures) will be injected into a vein in your arm. FDG, fluorodeoxyglucose, is a glucose analog which is taken up by high-glucose-using cells such as brain, kidney, and cancer cells. The combined FDG and NaF PET/MRI scan may provide improved information about the metabolism of musculoskeletal lesions. The table will move slowly through the tube-shaped PET/MRI scanner as it acquires the information needed to generate diagnostic images. Images of its distribution in your body will be acquired for approximately 45 minutes. You will be asked to lie very still during the scan because movement can interfere with the results. You will be asked to breath normally during the scan. During the scan, you might hear a humming noise but you will not feel anything unusual. You may feel the table move while images are being taken at certain locations on your body. Our technologist will monitor you during the exam. The whole-body MRI scanning procedure is very much like an x-ray CT scan. You may be given an IV (intravenous) contrast injection to enhance the results of your study. You will be asked to lie on a long narrow couch for about 45 minutes while the machine gathers data. During this time you will not be exposed to x-rays, but rather a strong magnetic field and radiofrequency magnetic fields. You will not feel either. You will, however, hear repetitive tapping noises that arise from the MR scanner. We will provide earplugs or headphones that you will be required to wear. The space within the large magnet in which you lie is somewhat confined, although we have taken many steps to relieve the "claustrophobic" feeling.
Clinical trial: NCT00375830
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?

You are invited to participate in a research study of the value of PET/MRI in detection of skeletal and soft tissue metastases. We hope to learn what is the best approach for detection of metastases and thus to improve cancer treatment. You were selected as a possible subject in this study because you are evaluated for presence of metastases. Your **participation** in this study is entirely voluntary. Your decision whether to participate or not will not prejudice you or your medical care. If you decide to participate, you are **free to withdraw** your consent, and to discontinue participation at any time without prejudice to you or effect on your medical care. If you decide to terminate your participation in this study, you should notify Dr. Andrei Iagaru, the Protocol Director, at 650-7254711. This research study is looking for people with cancer who are screened for skeletal and soft tissue metastases at Stanford. Stanford University expects to enroll 170 research study subjects.

This study will attempt to correlate the results of bone scans with PET/MRI, in order to determine the best approach for skeletal and soft tissue metastases identification. This should improve the diagnosis and/or management of cancer. Your health information related to this study, including but not limited to your medical history, lab results, and imaging results, may be used to correlate with the PET/MRI results.
Clinical trial: NCT00375830
Section: Voluntary Participation
Subsections: 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.
Clinical trial: NCT00375830
Section: Withdrawal from Study
Subsections: Withdrawal From Study|If I Sign, Can I Revoke It Or Withdraw From The Research Later?

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.  
IRB Use Only  
  
  
Approval Date: April 26, 2019 Expiration Date:
If you withdraw from the study, your images will not be analyzed.  
The Protocol Director may also withdraw you from the study for one or more of the following reasons:
o Failure to follow the instructions of the Protocol Director and/or study staff. o The Protocol Director decides that continuing your participation could be harmful to you. o The study is cancelled. o Other administrative reasons.  
o Unanticipated circumstances.

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 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 at 300 Pasteur Dr, H2200, Stanford, CA 94305.