Clinical trial: NCT03565367
Section: Alternatives
Subsections: Alternatives

The alternative is not to participate in this Study. Choosing to not participate in this Study will not affect the care you receive at Stanford Hospital.
Clinical trial: NCT03565367
Section: Confidentiality
Subsections: Future Use Of Private Information|Confidentiality|Authorization To Use Your Health Information For Research Purposes|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?

Research using private information is an important way to try to understand human disease. You are being given this information because the investigators want to save imaging data with private information for future research. All study files and images will be labeled with a subject identification (ID) number and possibly initials. Identifiers might be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.

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. The purpose of this research study is to obtain data or information on the safety and effectiveness of hyperpolarized [1-13C]-pyruvate; the results will be provided to the sponsor, the Food and Drug Administration and other federal and regulatory agencies as required.  
  
  
Approval Date: October 19, 2021 Expiration Date: October 19, 2022  
Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)

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. Lawrence Recht - The IND Holder, Dr. Daniel Spielman - The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
- Research Staff  
  
  
Approval Date: October 19, 2021 Expiration Date: October 19, 2022  
Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)

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 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. When will my authorization expire? Your authorization for the use and/or disclosure of your health information will end on December 31, 2050 or when the research project ends, whichever is earlier. Will access to my medical record be limited during the study? 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). ________________________________ ______________
Signature of Adult Participant Date ________________________________ Print Name of Adult Participant  
  
  
Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
Clinical trial: NCT03565367
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This research study is expected to take approximately 3 days. Screening may take up to 14 days. During the first day of treatment, you will undergo the experimental procedure and afterwards, an EKG will be obtained. Once during the next 2-4 days, you will be contacted by the research study staff to collect information on any side effects of the procedure.
Clinical trial: NCT03565367
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.  
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Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)  
- 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: NCT03565367
Section: Participant's Rights
Subsections: Participant'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.

As a research participant you have the following rights. These rights include but are not limited to the participant'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;
- 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
Clinical trial: NCT03565367
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, **Discomforts, And Inconveniences**|Mri / Mrsi **Risks:**|If You Feel Discomfort At Any Time, Notify The Operator And You Can Discontinue The Exam At Any Time.|Hp-Pyruvate Risks:|Study Procedure Risks:|Compensation **For Research-Related Injury**

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.

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. You should also notify the operator/investigator if you have any tattoos on your body, including eyeliner and other Page 4 of 13  
  
  
Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
permanent makeup. Tattoos could become warm and irritated during the scan and remain so for several days. If you would prefer not to participate in the MR scan due to the presence of tattoos on your body, please inform a research team member. There is a possibility that you will experience a localized twitching sensation due to the magnetic field changes during the scan. This is not unexpected and should not be painful. However, you may have the scan stopped at any time if this occurs. There is also a possibility of tinnitus (ringing in the ears) after the MRI. 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. It has been observed that deposits of Gadolinium-based contrast agent (GBCA) remain in the brains of some people who undergo four or more contrast enhanced MRI scans, long after the last administration. It is not yet known whether these Gadolinium deposits are harmful or can lead to adverse health effects. You should talk to the study doctor if you have any questions about the use of GBCAs with MRIs.

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 merit 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.

In all clinical studies of HP-pyruvate performed to date, no dose-limiting side effects or toxicities deemed to be clinically significant were noted. However, it is possible some risks are currently unknown or unforeseeable. We will not exceed the maximum dosages used in prior studies. In other clinical studies of HP-pyruvate, the following adverse events were noted:
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Blood Draw: Blood sampling and needle punctures carry some risk. Possible side effects include, but are not limited to fainting, bleeding, bruising, discomfort, dizziness, infection and/or pain at the puncture site. Rare but permanent nerve damage can occur. ECG Risk: An electrocardiogram (ECG) is a harmless and painless test with no serious risks. The ECG detects the heart's electrical activity and don't give off electrical charges, such as shocks. You may develop a mild rash where the electrodes (soft patches) were attached, which may go away without treatment.

All forms of medical diagnosis and treatment - whether routine or experimental - involve some risk of injury. In spite of all precautions, you might develop medical complications from participating in this study. If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment. In the event that you have an injury or illness that is directly caused by your participation in this study, reimbursement for all related costs of care first will be sought from your insurer, managed care plan, or other benefits program. You will be responsible for any associated co-payments or deductibles as required by your insurance. If costs of care related to such an injury are not covered by your insurer, managed care plan or other benefits program, you may be responsible for these costs. If you are unable to pay for such costs, the Protocol Director will assist you in applying for supplemental benefits and explain how to apply for patient financial assistance from the hospital. You do not waive any liability rights for personal injury by signing this form.
Clinical trial: NCT03565367
Section: Procedures
Subsections: Procedures

If you choose to participate, the Protocol Director Dr. Lawrence Recht and his research study staff will describe all procedures to be followed.  
Screening If you sign the informed consent form and agree to participate, the following screening procedures will be performed within 14 days prior to Day 1:
- Collect demographics
- Measure vital signs (heart rate, temperature, blood pressure), height and weight
- Blood drawn for laboratory safety tests, totaling 1-2 teaspoons - Electrocardiogram (ECG): An ECG detects the heart's electrical activity through sticky pads attached to your body
- **If you are a female capable of bearing children**, you will be required to have a blood (less than 1 teaspoon) pregnancy test.
Clinical trial: NCT03565367
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 to assess the safety of infusing 13C-labeled hyperpolarized pyruvate (HP-pyruvate) prior to performing magnetic resonance spectroscopic imaging (MRSI). HP-pyruvate is "investigational", meaning that it is not approved by the US Food and Drug Administration (FDA) for use outside clinical research studies. Pyruvate is a naturally produced sugar intermediate in your body that is essential for making energy. Hyperpolarized MRSI is a new technology that enhances our ability to image the pyruvate by changing its magnetic properties, but otherwise the labeled pyruvate is identical to the sugar intermediate in your body. The hyperpolarized pyruvate is non-toxic and non-radioactive, and will be metabolized by your body is the same rapid manner as all naturally produced pyruvate. In part because of their rapid growth rate, all cancer cells convert (metabolize) sugar into energy differently from normal cells. Investigators hope to learn whether an IV infusion of hyperpolarized pyruvate can be used to measure the metabolic state of malignant brain tumors. You were selected as a possible participant in this study because you have been diagnosed with Central Nervous System (CNS) malignancy. Investigators believe finding drugs that reverse the abnormal cancer metabolism would be effective in slowing cancer growth with minimal side effects on normal cells. However, there is currently no good way to detect this abnormal cancer metabolism in patients. This research study hopes to test the use of hyperpolarized pyruvate as a way to detect abnormal cancer metabolism, which could help investigators study new ways to treat cancer. If you decide to terminate your participation in this study, you should notify Dr. Lawrence Recht at (650) 498-6000. This research study is looking for 5 healthy volunteers and 10 participants with a diagnosis of CNS malignancy, including metastases, who are eligible to undergo MRI. Stanford University expects to enroll 15 research study participants.

This is a clinical research study to evaluate the safety and efficacy of hyperpolarized [113C]-pyruvate, an investigational agent. Your health information will be used to verify the study conduct and data entry, assess the study drug effects, and prepare regulatory documents for submission to FDA. Your coded information may also be used in research related to the study drug, your cancer and related diseases, and/or diagnostics to inform treatment; or in scientific publications.
Clinical trial: NCT03565367
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.  
  
  
  
Protocol Title: A Pilot Study to Assess lactate and bicarbonate detection within Malignant Brain Tumors using [1-13C]-pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
Clinical trial: NCT03565367
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.  
Lawrence Recht at (650) 498-6000.  
The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:
o Failure to follow the instructions of the Protocol Director and study staff. o The Protocol Director decides that continuing your participation could be harmful to you.  
o Pregnancy o The study is cancelled. o Other administrative reasons. o Unanticipated circumstances.