Clinical trial: NCT03405142
Section: Alternatives
Subsections: Alternatives

You do not have to participate in this study. The alternative to participating in this study is to undergo your planned surgical procedure without the additional injection of radiotracer or panitumumab-IRDye800 and the study related imaging and follow-up visits.
Clinical trial: NCT03405142
Section: Confidentiality
Subsections: Confidentiality|Authorization To Use Your Health Information For|Who May Use Or Disclose The Information?|Who May Receive Or Use The Information?

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 panitumumab-IRdye800; the results will be provided to the sponsor, the FDA and other federal and regulatory agencies as required.  
  
  
  
  
  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer

Research Purposes  
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. Fred Baik The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary Research Staff

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 The National Cancer Institute Northern California Cancer Registry 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.  
  
IRB Use Only  
  
  
  
Approval Date: April 6, 2021 Expiration Date: November 3, 2021  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer When will my authorization expire? Your authorization for the use and/or disclosure of your health information will end on December 31st 2067, or when the research project ends, whichever is earlier.  
________________________________ ______________
Signature of Adult Participant Date
________________________________ Print Name of Adult Participant If authorization is to be obtained from a legally authorized representative -- e.g.,
parent(s), legal guardian or conservator
_______________________________ ______________ 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:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer
Clinical trial: NCT03405142
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This research study is expected to take approximately 2 years whereby you would participate for up to two months. The screening period will take up to 30 days. Your active study participation will take 30 days from the start of treatment.
Clinical trial: NCT03405142
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.  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer Tell the Protocol Director or research staff if you change your mind about staying in the study.
Clinical trial: NCT03405142
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. 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.

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.  
  
  
| IRB Use Only                                                   |
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| Approval Date: April 6, 2021 Expiration Date: November 3, 2021 |  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer 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 When consent is obtained from a legally authorized representative (LAR) or representatives (e.g., parent(s), guardian or conservator): _____________________________________ ____________ 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) _____________________________________ ____________
(If available) Signature of Other Parent or Guardian Date _____________________________________ _________________________ Print Name of Other Parent or Guardian Authority to Act for Participant _____________________________________ ____________ Signature of Person Obtaining Consent Date _____________________________________ Print Name of Person Obtaining Consent Participant ID:  
  
IRB Use Only  
  
  
  
  
  
  
Approval Date: April 6, 2021 Expiration Date: November 3, 2021 Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer 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
__________________________________ Print Name of Witness (e.g., staff, translator/interpreter, family member)
Translated short form must be signed and dated by both the participant (or their LAR) AND the witness.  
The English consent form (referred to as the "Summary Form" in the regulations):
Must be signed by the witness AND the Person Obtaining Consent (POC). The non-English speaking participant/LAR does not sign the English consent. The non-English speaking participant/LAR should not sign the HIPAA participant line If the participant or the LAR is non-English speaking, the Person Obtaining Consent (POC) must ensure that 1) the LAR's Description of Authority is completed and 2) that any questions or options presented by the consent form are documented and initialed by the POC on the Summary Form, per the participant's wishes, as they are understood during the consent process.
Clinical trial: NCT03405142
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, Discomforts, And Inconveniences|Panitumumab (Vectibix ®) Risks|Panitumumab-Irdye800 Risks|Risks Associated Lymphoseek (Applicable To Cohort 1 Only)|Study Procedure 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. Because Panitumumab-IRDye800 is investigational, you may experience side effects not yet known, or in greater severity than those listed below. We will tell you if we learn any new information that may affect your health, welfare, or decision to stay in this study. You should talk to your study doctor about any side effects that you have while taking part in the study.

Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer Many of the reported adverse events are associated with repeat administration of panitumumab, rather than the single dose that you will receive as part of this study. The total dose of panitumumab that you will receive will be lower than the usual total dose that is given to patients receiving it as treatment for cancer. The most common side effects patients have experienced when receiving panitumumab primarily include skin reactions (including acne-like rash, dry or itchy skin, cracking of skin around your nail beds, skin infections, and dry eyes), fatigue, nausea, and diarrhea. Monitor skin reactions carefully to prevent serious or life-threatening complications. Exposure to sunlight may make skin reactions worse; limit exposure by using sunscreen and protective clothing.  
Infusion reactions, including fever, chills, difficulty or labored breathing, and low blood pressure, occurred in 4% of patients taking panitumumab. These reactions are most likely during or immediately following panitumumab infusion. Severe infusion reactions occurred in 1% of patients. You may be given a drug in your IV prior to the panitumumab infusion to help prevent these types of reactions. This will be determined by your study doctor. The most common drug that is given is an antihistamine called diphenhydramine (Benadryl). Based on your study doctor's routine practice, he or she may decide to give other drugs, such as steroids, if it's felt necessary to treat a reaction. *Tell your doctor or nurse immediately if you experience any* of the symptoms of an infusion reaction. Patients receiving repeated doses of panitumumab occasionally had progressively decreased magnesium and/or other minerals in the blood. Your blood chemistry levels will be monitored closely during this study, and electrolyte replacement will be given if necessary. There have been rare reports of patients experiencing fatal and non-fatal lung disease after treatment with panitumumab. You should notify your study doctor if you have ever had lung disease. Notify your study doctor immediately if you experience sudden or worsening breathing troubles.

The study drug has been tested in over 60 humans with head and neck cancer so far with no observed side effects or related adverse events. We do not believe that the study drug will increase your chances of experiencing known side effects from treatment with panitumumab; however, we do not know this for sure. Despite extensive efforts to assure your safety, other unexpected side effects could occur. Animals given this study drug did not experience any severe side effects. There were heart rhythm changes during the infusion; however, the animals did not experience any physical problems during the infusion or during the monitoring period for 2 weeks after the infusion. Nevertheless, these heart rhythm changes are considered abnormal heart rhythms and could indicate serious side effects resulting in death.  
  
  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer Reproductive Risks Based on data from animal studies, panitumumab may cause fetal harm (organ damage, death) when administered to pregnant women.

As of today, Lymphoseek has been evaluated and validated >550 patients with breast cancer, melanoma and/head-and-neck cancer. None of the patients studied with either experienced serious adverse reactions. The side effects injection site irritations (0.7% (4 patients)) and pain (0.2% (1 patient) were reported. Lymphoseek might pose a risk of hypersensitivity reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs). Please notify the investigator about previous hypersensitivity reactions to drugs, in particular dextran and modified forms thereof. Radiation Risk Sentinel Node Biopsy Procedure: Any radiation-emitting product may increase risk for cancer. We will adhere to the dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to you, your family or health care workers. This procedure would be performed in routine care regardless of a patient's participation in this study.

Blood Draw/IV: Inserting a needle into your arm for drawing blood, or an IV catheter for infusion, can cause slight discomfort or bruising at the puncture site. Lightheadedness or fainting may occur. Rarely, an infection at the puncture site may occur.  
ECG: The adhesive pads used during this procedure may cause mild skin irritation or pull out some hairs when removed.  
Injection Sentinel Node Tracer: Insertion of a needle in the oral cavity (i.e. tongue or floor of mouth), can cause discomfort. Lightheadedness or fainting may occur. Rarely, an infection at the puncture site may occur.  
Sentinel Node Imaging: When performing imaging, movement restrictions apply as such to gather the best images possible. For acquisition of the low-dose CT scan you will be positioned in a small tunnel, this might lead to slight claustrophobic feelings.
Clinical trial: NCT03405142
Section: Procedures
Subsections: Procedures

If you choose to participate, Dr. Baik and his research team will perform the following procedures in addition to your normal pre-operative, surgery and follow-up clinic visits and examinations:
Clinical trial: NCT03405142
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 determine the ability of panitumumabIRDye800 to identify head and neck cancer that has spread to the lymph nodes (metastatic lymph nodes). Currently, to identify the presence of metastatic lymph nodes during surgical resection of head and neck cancers, patients undergo a neck dissection or sentinel node biopsy whereby some or all of the lymph nodes are taken out of the neck and sent for pathological evaluation. We hope to show that panitumumab-IRDye800 can help surgeons to identify  
  
  
  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer metastatic lymph nodes during the surgical procedure with equal or better accuracy than the current methods. You are being offered this study because you have primary or recurrent head and neck cancer and your doctor has recommended surgery including a selective or radical neck dissection as treatment to remove the primary tumor and lymph nodes of the neck. If you decide to terminate your participation in this study, you should notify Dr. Fred Baik at or after hours at (650)-498-6000.  
This research study is looking for 20 patients with head and neck cancer that are scheduled to undergo surgery for removal of the primary tumor and/or lymph nodes of the neck. Stanford University will be the only site to enroll research study participants for this study.

The purpose of this study is to evaluate the effectiveness of PanitumumabIRDye800 in head and neck cancer patients. Your health information will be used to verify the study conduct and data entry, assess the study treatment effects, and prepare regulatory documents for submission to Stanford institutional review, the FDA, and/or other national regulatory agencies for marketing approval. 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.
Clinical trial: NCT03405142
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.
Clinical trial: NCT03405142
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. Fred Baik at or after hours at (650)-498-6000. If you withdraw from the study, or the study medication is stopped for any reason, you will be asked to return for a safety visit 30 days after receiving panitumumab-IRDye800. You should notify Dr. Fred Baik if you also withdraw consent for investigators to use your tissue samples for research.  
The Protocol Director may also withdraw you from the study and the study medication may be stopped 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 You become pregnant or start breast feeding. o Severe infusion reaction to panitumumab-IRDye800 dose requiring stopping the infusion.  
o You need treatment not allowed in the study.  
o The study is cancelled.  
o Other administrative reasons.  
o 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  
  
  
  
Protocol Title:
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective)
Neck Dissection for Metastatic Lymph Node Identification in Patients with Head and Neck Cancer research use or disclosure of your health information in this study, you must write to:
Dr. Fred Baik 875 Blake Wilbur Drive Stanford, California 94305 What Personal Information Will Be Obtained, Used or Disclosed? Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to, your personal information (such as name, address, telephone number, date of birth);
demographics (e.g. gender, race, ethnicity); medical history (especially cancer and surgical history); information from laboratory tests, imaging procedures, physical exams and other study tests or procedures; and information learned during research office visits.