Clinical trial: NCT02141490
Section: Alternatives
Subsections: What Are The Alternatives For Diagnosis Or Treatment?

This is not a treatment trial. The alternative is not to participate. If you do not consent to this trial, you will not be deprived of any treatment for which you are otherwise entitled.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0107 CONTINUATION: page 6 of 9 pages
Clinical trial: NCT02141490
Section: Confidentiality
Subsections: Will Your Medical Information Be Kept Private?

We will do our best to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Organizations that may look at and/or copy your medical records for research, quality assurance, and data analysis include:  
- The National Cancer Institute (NCI) and other government agencies, like the Food and Drug Administration (FDA), which are involved in keeping research safe for people.  
- National Cancer Institute Institutional Review Board
Clinical trial: NCT02141490
Section: Duration of Study Involvement
Subsections: During The Study|How Long Will You Be In The Study?

If you are eligible for this study and wish to participate, you will then be scheduled for study procedures including ultrasonography, MRI imaging and Ferumoxytol infusion. These activities will be performed in the NCI Molecular Imaging Clinic except for the ultrasonography, which will be performed in the Radiology and Imaging Sciences Department of Clinical Center, NIH. If you are women, an additional pregnancy test will also be done within 48 hours prior to Ferumoxytol infusion if more than 48 hours have passed since the screening test. The first MRI before Ferumoxytol infusion will take approximately 1 hour, whereas the first ultrasound examination will take about 10-15 minutes. Twenty-four hours after Ferumoxytol infusion, you will have a second MRI scan and an ultrasound examination, which will again take approximately 1 hour and 10-15 minutes, respectively. Finally, forty-eight hours after Ferumoxytol infusion, you will have a third MRI scan and an ultrasound examination. Ultrasonography is a medical imaging technique used to visualize internal organs to capture their size, structure and any pathological lesions with real time images. This technique uses harmless sound waves to provide pictures of organs or tissues inside the body. During the MRI scan, a standard sensor, which is like a small blanket with wiring inside, will be wrapped around your lower torso to improve MRI quality. The MRI scan usually takes less than  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0107 CONTINUATION: page 3 of 9 pages an hour. You will need to lie still on the scanning table during that time. An intravenous line (IV; a very thin catheter inserted into a vein with a tiny needle) will be started after your first MRI scan and Ferumoxytol will be injected into your system as an IV infusion. You will receive more information about your MRI scan when you visit the Molecular Imaging Clinic and you may ask questions at any time. In addition, you should ask your doctor or the study doctor any questions you have concerning this study. After imaging has been completed, your referring physician will treat your disease per the treatment protocol you are enrolled on. If you have surgery to remove lymph nodes or a biopsy after the MRI scan, your tissue will be reviewed in the NCI pathology department to determine if the imaging agent was able to detect involvement of your lymph nodes. If you do not have surgery to remove lymph nodes or a biopsy, the research team will review your medical records to determine if the imaging agent was able to detect involvement of your lymph nodes.

Participation in this study will last until you have had the forty-eight hour ultrasonography and MRI completed. The active part of the study, (Ferumoxytol infusion, ultrasonography, and MRI
scanning) will last a few days.  
However, patients that do not undergo surgical excision or a biopsy to remove lymph nodes will remain on study for a minimum of 12 months. It is expected to take approximately 24 months for this study to enroll all patients.
Clinical trial: NCT02141490
Section: Participant Responsibilities
Subsections: What Do I Have To Do?

Read this informed consent and take the time to get answers to all your questions. You will be provided a copy of this consent once you, the investigator and a witness have signed the form. You will need to provide your doctor with a listing of all your current medications as certain medications may react with the study infusion.
Clinical trial: NCT02141490
Section: Participant's Rights
Subsections: Research Subject'S **Rights** What Are The Costs Of Taking Part In This Study?

If you choose to take part in the study, the following will apply, in keeping with the NIH policy:  
- You will receive study treatment at no charge to you. This may include surgery, medicines, laboratory testing, x-rays or scans done at the Clinical Center, National Institutes of Health (NIH), or arranged for you by the research team to be done outside the Clinical Center, NIH if the study related treatment is not available at the NIH.  
- There are limited funds available to cover the cost of some tests and procedures performed outside the Clinical Center, NIH. You may have to pay for these costs if they are not covered by your insurance company.  
- Medicines that are not part of the study treatment will not be provided or paid for by the Clinical Center, NIH.  
- Once you have completed taking part in the study, medical care will no longer be provided by the Clinical Center, NIH.  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0107 CONTINUATION: page 7 of 9 pages A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Clinical trial: NCT02141490
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Possible Risks / Discomforts? Risk From Blood Draws|Risks From Ultrasonography|Risks From Mri|Risks From Ferumoxytol

The risks associated with the blood draws and IV insertion includes:  
- pain at the needle site;
- bruising;
- possible dizziness if you stand up quickly; and
- possible inflammation of the vein or infection at the needle site.

The ultrasonography procedure will take about 10-15 minutes. Ultrasonography has no known risks with no use of ionizing radiation or adverse heating or pressure effects in tissue.

Having an MRI requires that you lie still with part of you or all of you inside a tube shaped machine for about 45 minutes to an hour. Even with the ear plugs we give you it can be noisy with loud clicking and thumping sounds, which bothers some people. Some people may feel 'closed in' or 'trapped' (even though they being closely watched and are quite safe). This is  
PATIENT IDENTIFICATION CONTINUATION SHEET for **either:**  
NIH-2514-1 (07-09)  
NIH-2514-2 (10-84)  
P.A.: 09-25-0099  
File in Section 4: Protocol Consent  
STUDY NUMBER: 14-C-0107 CONTINUATION: page 5 of 9 pages called claustrophobia. Cool air will surround you, and the room is large and brightly lit to help avoid claustrophobia. You may ask your physician for a mild sedative for the procedure if you think it will help. If you take a sedative you must not drive a vehicle until it wears off after the MRI. MRI scans cannot be done on people who have:  
- a cardiac pacemaker, - neural pacemaker, - surgical metal clips in the brain or on blood vessels,
- cochlear implants,
- or foreign metal objects within the eye. At the time of your MRI, you will be asked about these things.

Ferumoxytol has been generally safe when given to people for its FDA approved purpose of iron replacement therapy. Side effects, some of which can be serious or life threatening, may sometimes occur. These side effects, though rare, may happen in this trial. If they do happen it is usually right around the time that Ferumoxytol is injected, which is why you will be closely watched at that time, and promptly treated if necessary. These effects include:  
- whole body allergic reactions, which can range from mild to serious or life threatening
(this is called anaphylaxis),
- low blood pressure, which can lead to becoming unconscious (fainting, passing-out)
- iron overload.
One person who took part in a prior study in NCI experienced a mild allergic reaction while the Ferumoxytol was being given. It was promptly treated and got better right away. Again, you will be closely observed during and right after the Ferumoxytol is given so that if any reaction occurs it can be immediately treated. The dose used in this study is less than that used for iron replacement therapy. It is always possible that you may experience some side effects that we cannot anticipate.
Clinical trial: NCT02141490
Section: Procedures
Subsections: What Will Happen If You Take Part In This Research Study? Before You Begin The Study

For your safety, and to help make sure the results of this trial are scientifically meaningful, your medical history will be reviewed to make sure you are eligible to take part. At your first study visit, three vials of blood will be drawn for a panel of routine blood tests, you will have a physical exam, and your vital signs (blood pressure, heart rate, breathing rate and temperature) will be measured. If you are a woman able to get pregnant, you will also have a pregnancy test done. You will also answer questions about your medical history and current medications.
Clinical trial: NCT02141490
Section: Purpose of Research
Subsections: Purpose Of The Study|Why Are You Being **Asked To Take Part In This Study?**

The purpose of this study is to help researchers determine how well Ferumoxytol can detect  
 lymph node metastases in patients with prostate, bladder, or kidney cancer. Ferumoxytol is an FDA-approved iron replacement therapy agent. However, it is NOT approved by the FDA as an imaging agent. So the use Ferumoxytol in this protocol is experimental.  
STUDY NUMBER: 14-C-0107 CONTINUATION: page 2 of 9 pages

You are being invited to take part in a research study because you have one of the following types of cancers: prostate, bladder, or kidney and you may have surgery to remove your cancer or a biopsy to remove some tissue from your lymph nodes here at the Clinical Center. The decision to have surgery or a biopsy will not be made as a part of this study. This study will not affect your ability to take part in other research protocols or receive medical care. How many people will take part in this study?  
Up to 56 people will be included in this study.
Clinical trial: NCT02141490
Section: Withdrawal from Study
Subsections: Stopping Participation In This Study

Your study doctor may remove you from the study if:  
- they think it is in your best interest;
- if you do not follow the study instructions; or
- if you are found to be pregnant before you receive Ferumoxytol - for administrative reasons
In this case, you will be informed of the reason your participation is being stopped. You can stop taking part in the study at any time. However, if you decide to stop taking part in the study, we would like you to talk to the study doctor and your regular doctor first. If you decide at any time to withdraw your consent to participate in the trial, we will not collect any additional medical information about you. However, any data generated from the scans that have already been distributed to other researchers or placed in the research databases cannot be recalled and destroyed.