Clinical trial: NCT02387840
Section: Alternatives
Subsections: Are There Benefits To Taking Part In The Study?|What Other Options Are There?

We hope that your MRF scans will help your doctors interpret your regular MRI better. Your participation in this study may provide more accurate MRI images of your illness than a standard MRI study, and may help your doctors identify abnormal tissue. Your regular MRI scan will be reviewed by a radiologist, and MRF scans will be available to your radiologist. Your participation in this study may help us determine whether MRF is practical in children and whether MRF can help us learn more about children's brain tumors.

You have the option to not participate in this study. There will be no difference in your care if you choose not to participate.  
Fingerprinting Principal Investigator: Deborah Rukin Gold, MD
Clinical trial: NCT02387840
Section: Confidentiality
Subsections: What About Privacy?|Hipaa Authorization Section Authorization To Use Or Disclose (Release) Health Information That Identifies You For A Research Study

All results relating to the study will be kept secure in a password-protected database at Rainbow Babies and Children's Hospital/Cleveland Medical Center. Access to this information is strictly limited to the Principal Investigator, study doctors and authorized study personnel. You will be assigned a study number to keep your identity confidential. Absolute confidentiality cannot be guaranteed. If the study results are published in medical or scientific journals, you will not be identified. Data from this study will also be sent to an outside institution for review.

If you volunteer to participate in this research, your protected health information (PHI) that identifies you will be used or disclosed to Deborah Rukin Gold, MD, and the research study staff at University Hospitals for the purposes of this research and to Case Western Reserve University for administration.  
Protocol Date: 11/21/2016 Version 11 Consent Date: 10/31/2017 Page 4 of 7
Clinical trial: NCT02387840
Section: Duration of Study Involvement
Subsections: How Long Is The Study?

If you have a tumor, we will collect information about you and your tumor for the next 5 years. All other participants will have MRF added to their regular scans over the next year. You may decide to take yourself off the study at any time by talking with your doctor or the principal investigator. Your doctor may decide to take you off this study if he/she believes that it is in your best interest or if your care is transferred from your hospital to another hospital.
Clinical trial: NCT02387840
Section: Participant's Rights
Subsections: Summary Of Your Rights As A Participant In A Research Study

Your participation in this research study is voluntary. Choosing not to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are otherwise entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits. If information generated from this study is published or presented, your identity will not be revealed. In the event new significant information becomes available that may affect the risks or benefits associated with this study or your willingness to participate in it, you will be notified so that you can decide whether or not to continue participating.
Clinical trial: NCT02387840
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Side Effects Or Discomfort Can I Expect From Being In The Study?|Research Related Injury

Some patients complain of claustrophobia or the sensation of being enclosed in a small space when inside the large tube of the MRI machine. MRF may increase the time spent in this tube by about 15 minutes. If you are uncomfortable during the scan, we can stop the scan. If you are sedated (given medicine to make you calm or sleepy) during your scan, taking MRF scans may involve about 15 more minutes under sedation. In addition, there is always a risk of losing confidentiality but we will work our hardest to keep your information safe in a secured, password-protected database accessible only to the principal investigator and study coordinator.

If injury occurs as a result of your involvement in this research, medical treatment is available from University Hospitals or another medical facility but you/your medical insurance will be responsible for the cost of this treatment. A research injury is an injury that happens as a result of taking part in this research study. If you are injured by a medical treatment or procedure that you would have received even if you weren't in the study, that is not considered a "research injury". There are no plans for payment of medical expenses or other payments, including lost wages, for any research-related injury. To help avoid injury, it is very important to follow all study directions. Further information about research-related injuries is available by contacting the University Hospitals Cleveland Medical Center's Research Subject Rights phone line at (216) 983-4979.
Clinical trial: NCT02387840
Section: Procedures
Subsections: What Will Happen On This Study?

After signing this Consent Form, you will be enrolled in the study. If you consent to the study, the following will happen. We will review your medical records and any past MRIs to determine if you meet the requirements for the study. During this review we will document your age, gender, and whether you have neurofibromatosis type 1. If you have an optic pathway glioma, we will also document your most recent eye doctor exam. During your next brain MRI, MRF will be performed. This test will be the same as your regular MRI, except for the computer software used to control the scanner and process the data, and the antenna placed inside the MRI machine and next to your body to receive radio waves. MRF will take about 15 additional minutes and does not use radiation. If you have regular MRI scans, MRF will be repeated during these scans over the next year. If you have a tumor that will be removed with surgery, MRF will be repeated after your surgery is  
Fingerprinting Principal Investigator: Deborah Rukin Gold, MD
complete. If your tumor comes back, MRF will be performed at that time, as well. Tumor pathology and type of therapy will also be recorded. All information will be kept confidential. The principal investigator, study doctors and authorized study personnel will be the only people who will be able to access this information. Your participation in this study will not impact your typical care.
Clinical trial: NCT02387840
Section: Purpose of Research
Subsections: Why Are You Being Asked To Take Part In This Study?|Why Is This Study Being Done?

You are being asked to participate in a research study of magnetic resonance fingerprinting (MRF) because your doctor has requested a MRI of your brain. MRF is a new MRI method that may be faster and better than traditional MRI. This study will examine the usefulness of MRF in people with brain tumors. This Consent Form describes the study and your role in it as a participant. Your study doctor or study staff member will answer any questions you have about this study or this consent form. You are to read this form carefully and ask any questions you have regarding the information it contains.  
Please Note: This Consent Form may contain words that you do not understand. Please ask your study doctor or a study staff member to explain words that you do not clearly understand. You may discuss the study with family, friends or anyone you choose before making a decision  
Fingerprinting Principal Investigator: Deborah Rukin Gold, MD
to participate. This form is only one part of the informed consent process. The study doctor or study staff will explain this form and the study to you in detail. Do not sign this form unless the study doctor or study staff has answered your questions and you decide that you want to participate.

The goal of this study is to determine whether MRF is practical and whether it offers more information about brain tumors. MRF is a type of fast MRI that may give more information about brain and tumor tissues than traditional MRI. MRF may help tell tumor from normal tissue or show where tumor is hidden among normal tissue. It may also tell when treatments are working in the tumor. In this study, we are asking people with and without brain tumors to have MRF performed during their traditional MRI. In people with brain tumors, we will also look at characteristics of your tumor. The information collected from this study will be very valuable if MRF can reduce the time that people spend in the MR scanner. It may also be useful in giving doctors more information about children's brain tumors or about your brain.