Clinical trial: NCT02287675
Section: Alternatives
Subsections: Alternative Treatment

You do not need to be in this study to receive Lymphoseek® or sulfur colloid to identify sentinel lymph nodes. You can receive the same treatment without being in this study.
Clinical trial: NCT02287675
Section: Confidentiality
Subsections: How Will My Information Be Protected?|Authorization To Use And Disclose Information For Research Purposes|Who Might Get This Information?

All information that you give will be kept strictly confidential. The information collected about you usually will not directly identify you (for example, by name, address, or social security number). Instead, your initials and a code number will be used for your information.  
Your records may be reviewed by:  
- The study sponsor. - People who work with the sponsor on the study.  
- Government agencies, such as the FDA. - Copernicus Group Independent Review Board (IRB). The IRB is a group of scientists and non-scientists who review the ethics of research. The goal of the IRB is to protect the rights and welfare of study subjects.
These people may look at your records to make sure the study has been done the right way. They also want to make sure that your health information has been collected the right way, or for other reasons that are allowed under the law. If information about this study is published, you will not be identified. There is a risk of loss of confidentiality in research studies. Every effort will be made to protect you and your health information to the extent possible.

Federal regulations give you certain rights related to your health information. These include the right to know who will receive the information and how it will be used. The study doctor must obtain your authorization (permission) to use or release any health information that might identify you. What information may be used and given to others? The study doctor will get your personal and medical information. For example:  
- Past and present medical records. - Research records.  
- Records about phone calls made as part of this research.  
- Records about your study visits. - Information that includes personal identifiers, such as your name, or a number associated with you as an individual.  
- Information gathered for this research about:
o Physical exams. o Laboratory, x-ray, and other test results.  
- Records about any study drug you received.
Who may use and give out information about you? The study doctor and the study staff.

The sponsor of this research - Kettering Medical Center. "Sponsor" means any persons or companies that are:  
- working for or with the sponsor, or
- associated with the sponsor to conduct this research study, such as Navidea Biopharmaceutical, the company funding this research.  
Your information may **be given to:**
- The U.S. Food and Drug Administration (FDA), - Department of Health and Human Services (DHHS) agencies,
- Governmental agencies in other countries, and
- Copernicus Group Independent Review Board.  
Why will this information be used and/or given to others?  
- to do the research, - to study the results, and - to make sure that the research was done right.
If the results of this study are made public, information that identifies you will not be used.
Clinical trial: NCT02287675
Section: Duration of Study Involvement
Subsections: Visit 3: Follow-Up (After Surgery, By Telephone)

- About a week after your surgery, the study nurse will call you and ask about any side effects you have had since your surgery.
Ask us if you have any questions about the tests and procedures for the study.  
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: NCT02287675
Section: Participant Responsibilities
Subsections: What Will I Be Asked To Do In This Study?

Before you decide whether to be in this study, you should think about how the tests and study visits will affect your time away from work and your schedule. To be in this study, you must agree to:
Clinical trial: NCT02287675
Section: Participant's Rights
Subsections: What If I Decide Not To Give Permission To Use And Give Out My Health Information? Then You Will Not Be Able To Be In This Research Study. May I Review Or Copy My Information? Yes, But Only After The Research Is Over. When Will My Permission End?

There is no date at which your permission ends. Your information will be used indefinitely. This is because the information used and created during the study may be analyzed for many years, and it is not possible to know when this will be complete.
Clinical trial: NCT02287675
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts|Other Risks

It is possible the drug you are given could cause adverse (bad) reactions or discomfort. You should talk to your study doctor about any side effects that you have while taking part in the study. You may have a local injection site reaction from the Study Drug including swelling, redness, burning, or itching. These reactions are generally mild and do not require treatment.  
- Follow directions from the study staff.  
- Make and keep study appointments.  
- Give urine samples as requested. - Tell the study staff about all of the medicines you have taken for 7 days before beginning the study.  
- Tell the study staff about any changes to your health during the study. - Not be part of any other research study while participating in this study.
In clinical trials of Lymphoseek®, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (less than 1%). You should tell your study doctor if you have had any prior bad reactions the drug dextran, as this may make you more likely to have a bad reaction to Lymphoseek®.  
Adverse reactions from sulfur colloid that have been reported are rash, allergic reaction, urticaria (hives), severe whole body allergic reaction, and low blood pressure. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Vital blue dye has been shown to produce an allergic reaction in a small number of people. These reactions may include itching, swelling and in rare instances, shock. Serious allergic reactions may be life-threatening. You will be monitored to see if you develop this type of reaction. If you do, you will receive prompt treatment. If the Study Drug along with the vital blue dye does not work, and no sentinel lymph node is identified, all of the lymph nodes in the area may be removed by your study doctor. The effects of the Study Drug on sperm or egg development or on a developing child are not known. Females wanting to be in this study must not be pregnant or nursing. If you become pregnant while taking part in this study, notify the study doctor at once. Vital blue dye has also caused a change in color around the injection site that can be seen for up to 48 hours after injection. The Study Drug uses radiation. Radiation occurs naturally in the environment and is used in treating and examining subjects for medical reasons. Radiation exposure is cumulative (adds up over time). Radiation exposure increases other health risks including cancer. The amount of radiation received from the Study Drug is only slightly more than you would receive from a chest x-ray or about the amount of radiation you are exposed to naturally from the environment over a period of a few months. In addition to the risks or discomforts listed here, there may be other risks that are currently not known. Also, the risks or discomforts described may occur more often or be more severe than has been seen before. You should get medical help and contact the study doctor or staff if you have any of these or any other side effects during the study.

When taking any new drug, you should be careful until you know how it affects you before you:  
- Drive,
- Operate machinery, or - Need to be alert.
Clinical trial: NCT02287675
Section: Procedures
Subsections: Procedures|Visit 1: Informed Consent Visit (Pre-Surgery Visit)

This section will tell what you can expect to happen if you agree to be in the study. You may ask any questions about the study, and then, if you agree to participate, sign this consent form. After you have signed the consent form, the following procedures will be done:

This visit will take place at either your surgeon's office or the Innovation, Research & Grants office at Kettering Medical Center.  
- You will provide details about your medical history and answer questions from the study doctor. This information helps the study doctor determine your overall health.  
- You will be asked to list the medications you have taken over the last 7 days. - Information from a recent physical exam, including measurements of vital signs
(pulse, breathing rate, temperature, and blood pressure) will be recorded for this study.  
- Any new questions you've thought of since your doctor first talked to you about this study will be answered.
Visit 2: Administration of the Study Drug (Lymphoseek® or Sulfur Colloid) and Surgery.  
This visit will take place at the hospital beginning in the Nuclear Medicine department and then moving to the Surgical Department.  
Nuclear Medicine Imaging:  
- If you are of childbearing potential, you must have a negative urine pregnancy test in order to be in the study. This test will be done before the Study Drug injection.  
- You will be asked about any side effects you have had since your screening visit. - The Study Drug will be injected by the study doctor on the outside edge of the areola of the affected breast. You will be asked to rate your level of discomfort just prior to the injection and just after the injection using a visual pain rating scale that shows cartoon faces that correlate to a number that goes from 0 for no pain to 9-10 worst pain you have experienced.  
- After the injection of the Study Drug, you will have imaging (SPECT/CT) done for detecting the movement of the Study Drug through the tissues. The length of time for the injection procedure and imaging is approximately 60 minutes but may be as long as 150 minutes (2.5 hours).  
- During the injection and imaging process, your vital signs and any side effects will be recorded.
Surgery:  
- You will be prepared for surgery in the normal manner. - After the anesthesiologist puts you to sleep, your surgeon will inject the vital blue dye.  
- Your surgeon will use a hand-held radiation-detecting probe similar to a Geiger counter to measure the Study Drug in the lymph node(s).  
- As part of the surgical procedure, your surgeon will remove one or more lymph nodes for evaluation by the pathologist.  
- Your surgeon will complete your surgery and you will be followed in the usual manner as instructed by your surgeon.
Clinical trial: NCT02287675
Section: Purpose of Research
Subsections: Purpose Of The Study:

You are being asked to be in this study because you are currently undergoing treatment for breast cancer. One way to learn more about your cancer is to do a sentinel lymph node biopsy (removal). The primary purpose of this study is to see how well one of two  
different approved drugs helps us find the sentinel lymph node, which is the first lymph node(s) to which cancer cells are most likely to spread. There can sometimes be more than one sentinel node.
Clinical trial: NCT02287675
Section: Voluntary Participation
Subsections: Voluntary Participation And Withdrawal

Your participation in this study is voluntary. You may decide not to participate in this study. If you do participate, you may freely withdraw from the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled. Your decision will not change your future medical care. Your participation in this study may be stopped at any time by the study doctor without your consent because:
Clinical trial: NCT02287675
Section: Withdrawal from Study
Subsections: May I Withdraw Or Revoke (Cancel) My Permission?

Yes. Your authorization will not expire unless you change your mind and revoke it in writing. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date unless you have a side effect related to the study. Information that has already been gathered may still be used and given to others. If you withdraw from the study but do not withdraw your Authorization, new health information may be collected until this study ends.  
Is my health information protected after it has been given to others? There is a risk that your information will be given to others without your permission. Any information that is shared may no longer be protected by federal privacy rules.