Clinical trial: NCT03113617
Section: Confidentiality
Subsections: Confidentiality|Use And Disclosure Of Protected Health Information Authorization To Use Your Health Information For Research Purposes|What Personal Information Will Be Used Or Disclosed?|Who May Use Or Disclose The Information?|Who May Receive / Use The Information?|Will Access To My Medical Record Be Limited During The Study?

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.  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer 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. The purpose of this research study is to obtain data or information on the safety and effectiveness of 68Ga-RM2; the results may be provided to the Food and Drug Administration, as well as to Piramal Imaging and GE Healthcare.  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer

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, medical record  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer  
  
number, medical history, sex, age, diagnosis, results of scans and pathology review, physical examination, lab tests, and imaging tests such as x-rays, CT scans, MRI scans, bone scans, and ultrasounds studies.

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

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
- The Food and Drug Administration (FDA)
- Piramal Imaging - GE Healthcare 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.

To maintain the integrity of this research study, you may not have access to any health information developed as part of this study until it is completed. At that point, you would have access to such health information if it was used to make a medical or billing decision about you (e.g., if included in your official medical record).  
  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer
_____________________________ ______________
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)  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer
Clinical trial: NCT03113617
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

If you agree to take part in this study, your involvement will include 1 visit (up to 3 hours). The PET/MRI scan will require that you spend up to 3 hours in the Lucas Center for Imaging.
Clinical trial: NCT03113617
Section: Participant Responsibilities
Subsections: Participant Responsibilities

As a participant, your responsibilities include:
- Follow the instructions of the Protocol Director and study staff.  
- Keep your study appointments. If it is necessary to miss an appointment, please contact the Protocol Director or research study staff to reschedule as soon as you know you will miss the appointment.  
- 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.
While participating in this research study, you should not take part in any other research project without approval from the Protocol Directors of each study. This is to protect you from possible injury.
Clinical trial: NCT03113617
Section: Participant's Rights
Subsections: Participant'S Rights|Do I Have To Sign This Authorization Form?|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.

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.

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 arise;
- be given an opportunity to ask questions concerning the experiment or the procedures involved;  
  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer  
- 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 will receive 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)
_____________________________________ ____________ 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  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer
Clinical trial: NCT03113617
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, Discomforts, And Inconveniences|Pet Related Risks:

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. Risks, discomfort and inconveniences include:
- Time involved for the visits to the hospital
- Bruising at the venipuncture/IV site for the radiopharmaceutical injection

This research study involves exposure to radiation from the radioactive compound 68GaRM2. This radiation exposure is not necessary for your medical care and is for research purposes only. The additional amount of radiation exposure is about 4.76 mSv from PET, 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 necessary to obtain the research information desired.  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer  
- Physical risks - from study drug and procedures (e.g., venipuncture, exposure to radiation.  
- This procedure may involve risks to you that are currently unforeseeable.
Clinical trial: NCT03113617
Section: Procedures
Subsections: Procedures

Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer If you choose to participate, Dr. Andrei Iagaru and his research study staff will require the following:  
1. After signed the informed consent document, participants will be given a copy of the signed form.  
2. Participant will be asked to drink 1 to 2 glasses of water before arrival at the clinic 3. Participants will be weighed and vital signs (heart rate and blood pressure) will be recorded 4. Study personnel (eg, technologist) will verify subject identify; radiopharmaceutical identity; dose; and administration route. Participant will be injected IV with 140 MBq of 68Ga-RM2 5. Participant will void immediately prior to the scan 6. Approximately 50 to 100 minutes after the radiopharmaceutical IV administration, data acquisition will begin in the pelvic region and move toward the head. First, localizer MRI scans will be performed to define the table positions. After correct positioning of the spatial acquisition windows is ensured, the combined PET/MRI acquisition will be initiated with 3 to 5 table positions at a 4-min acquisition time per table position.  
7. Vital signs (heart rate and blood pressure) will be recorded again at the completion of the study. 8. Participants will be dismissed. 9. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring Adverse Events.  
Additional imaging/biopsy may be performed as a result of the research scan data at the discretion of the PI, Dr. Andrei Iagaru. 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 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. If you have had a previous reaction to Gadolinium-based contrast agents or a history of severe allergies, please notify the operator/investigator. If you have kidney problems, please tell the operator. You will be asked to lie on a long narrow couch for about 45-60 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. Your test results will be maintained as part of your Stanford medical record. If you do not have a Stanford medical record, one will be created during this research study.  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer If your partner is able to become pregnant, you and your partner must use adequate contraception while you are participating in the study. Your doctor will discuss with you what methods of birth control are considered adequate. You should inform your study doctor if your partner becomes pregnant.
Clinical trial: NCT03113617
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 were selected as a possible subject in this study because you have been diagnosed with prostate cancer and are scheduled for prostatectomy with lymph node dissection. The purpose of this research study is to see if your tumor can be identified using a special procedure called a positron emission tomography (PET) scan using a new radiopharmaceutical (68Ga-RM2).  
PET/MRI is used to describe information regarding the function, as well as location and size of a tumor. You will first have a an injection with a radioactive drug called 68Ga-RM2 that binds to tumor cells that have specific receptors and then have a PET scan. We believe this special PET/MRI scan will be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan.  
68Ga-RM2 is considered investigational in the US, which means that it has not been approved by the U.S. Food and Drug Administration (FDA).

This study will attempt to correlate the results of standard of care scans with 68GaRM2 PET/MRI scan, in order to determine the best approach for evaluation of extent of prostate 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. Your health information may be used in scientific publications, but your identity will not be disclosed.
Clinical trial: NCT03113617
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. If you decide to terminate your participation in this study, you should notify the research coordinators at 650-725-4711. This research study is looking for 90 research study participants newly diagnosed with prostate cancer. Enrollment in in this study will occur only at Stanford University. Stanford University expects to enroll 90 research study participants over 3 years.
Clinical trial: NCT03113617
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. If you decide to withdraw your consent to participate in this study, you should notify Dr. Andrei Iagaru at (650)-725-4711. You will receive a follow up phone call to ask if you had any adverse effects from your participation in the study. If you decided to withdraw from the study after the tracer is injected and before the scan is done we would like to observe you for any adverse reaction for up to an hour. Once the IV's have been removed it will be safe for you to leave.  
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  
  
Protocol Title: 68Ga-RM2 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients with Intermediate and High-Risk Prostate Cancer  
- 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.

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, 300 Pasteur Drive H2200, MC 5281, Stanford, CA 94305.