Clinical trial: NCT02424955
Section: Alternatives
Subsections: Alternatives

The alternative is not to participate. Your treatment and care will not be affected by your decision to participate or not participate. Participation/non-participation will not affect the routine radiologic evaluation of studies and clinical care of the patients.
Clinical trial: NCT02424955
Section: Confidentiality
Subsections: Authorization To Use Your Health Information For Research Purposes|Who May Use Or Disclose The Information?|When Will My Authorization Expire?|Confidentiality

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.  
  
  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation What is the purpose of this research study and how will my health information be **utilized in the study?** The purpose of this study is to test the feasibility of contrast enhanced 3D Ultrasound of the liver to evaluate whether perfusion characteristics
(measurement of blood flow) of primary or metastatic liver tumors can predict tumor response to treatment. You were selected as a possible participant in this study because you are identified as having primary liver tumor metastases and you are scheduled to be treated with Stereotactic Ablative Radiotherapy (SABR) for the first time. Your liver perfusion data will be deidentified and then analyzed. Images without any identification may be used in clinical presentations or publications.

The following parties are authorized to use and/or disclose your health information in connection with this research study:
- The Protocol Director (Dr. Daniel Chang)
- The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
- Research Staff Who May Receive or Use the Information? 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 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.

Your authorization for the use and/or disclosure of your health information will end on January 1, 2059, or when the research project ends, whichever is earlier.  
_____________________________________ ____________
Signature of Adult Participant Date  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation
_____________________________________
Print Name of Adult Participant

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. The results of this research study may be presented at scientific or medical meetings or published in scientific journals. However, your identity will not be disclosed. 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.
Clinical trial: NCT02424955
Section: Duration of Study Involvement
Subsections: Duration Of Study Involvement

This study will take approximately sixty minutes of your time for each Ultrasound scan. There will be 3 ultrasound scans, one prior to your scheduled Stereotactic Ablative Radiotherapy (SABR) treatment, one 0-7 days after your first fraction of radiotherapy treatment, and one 2-4 months from the start of your treatment.
Clinical trial: NCT02424955
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.  
  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation  
  
- Tell the Protocol Director or research staff if you believe you might be pregnant or gotten your partner pregnant.  
- Tell the Protocol Director or research staff if wear any implantable medical devices such as pacemakers, etc.  
- 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: NCT02424955
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 still receive care for your disease and will not lose any benefits to which you would otherwise be entitled. 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;  
  
  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation
- 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.  
May we contact you about future studies that may be of interest to you?  Yes  No Signing your name means you agree to be in this study and that you were given a copy of this consent form.  
_____________________________________ ____________ Signature of Adult Participant Date _____________________________________ Print Name of Adult Participant ____________________________________ ___________ Signature of Person Obtaining Consent Date ____________________________________ Print Name of Person Obtaining Consent 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 (e.g., staff, translator/interpreter, family member)
Clinical trial: NCT02424955
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks, **Discomforts, And Inconveniences**|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. You will undergo 3 additional Ultrasound scans which will take up to 1 hour of your time in total each session. Unlike CT scans, the Ultrasound Imaging does not require radiation. The contrast should not be administered to patients with blood flow shunting from one to the other heart chamber; also, in patients with known allergies to perflutren (Definity), the agent should not be administered.  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation

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,  
  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation 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: NCT02424955
Section: Procedures
Subsections: Procedures

If you choose to participate, Daniel Chang and his research study staff will ask you to participate in this study by undergoing an Ultrasound scan prior to your first Stereotactic Ablative Radiotherapy (SABR) treatment, one 0-7 days after your first fraction of radiotherapy treatment, and once in 2-4 months from the start of your treatment. These Ultrasound scans will be compared to the CT or MRI scans that will be done at approximately 2-4 months after the start of the SABR as part of routine care. They will be done in addition to and not instead of these routine scans. Each scan will be performed with an electromagnetic or optical tracking device attached to the Ultrasound probe. Definity will be administered through an IV (intravenously) into a central line or port or an upper extremity vein (wrist, hand, arm) using an IV catheter. 1.3mL of Definity will then be injected for 6-8 minutes. The contrast-enhanced ultrasound will be performed within these 8 minutes.  
  
  
  
  
Protocol Director: Daniel Chang, MD
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation All participants will be provided a consent form describing the study with sufficient information for participants to make an informed decision regarding their participation. Participants will sign an IRB approved informed consent prior to participation in any study specific procedure. The participant will receive a copy of the signed and dated consent document. The original signed copy of the consent document will be retained in the medical record or research file.  
If the subject is female and of child-bearing potential, pregnancy will be tested by:
- Serum βHCG or urine pregnancy test within 24 hours prior to the start of Definity®
administration (the local laboratory may be used)
- Surgical history (e.g., tubal ligation or hysterectomy) - Medical history (post-menopausal with a minimum of 1 year without menses).  
If you are a woman who is able to become pregnant, it is expected that you will use an effective method of birth control to prevent exposing a fetus to a potentially dangerous agent with unknown risk. If you are pregnant or currently breast-feeding, you may not participate in this study. You understand that if you are pregnant, if you become pregnant, or if you are breast feeding during this study, you or your child may be exposed to extra radiation. If you have had a previous reaction to contrast agents or a history of severe allergies, please notify the operator/investigator. If you have kidney problems, please tell the operator. To confirm to the extent medically possible that you are not pregnant, you agree to have a pregnancy test done before beginning this research study. You must agree to avoid sexual intercourse or use a birth control method judged to be effective by the investigator and which will not interfere with the proposed investigation. You must accept the risk that pregnancy could still result despite the responsible use of a reliable method of birth control. You agree to notify the investigator as soon as possible of any failure of proper use of your birth control method, or if you become pregnant, either of which may result in your being withdrawn from the study.
Clinical trial: NCT02424955
Section: Purpose of Research
Subsections: Purpose Of Research

You are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. You were selected as a possible participant in this study because you are identified as having liver metastases. If you decide to terminate your participation in this study, you should notify Daniel Chang, M.D. at 650-724-3547.  
This research study is looking for 20 people with a primary or metastatic liver tumor, which can be imaged with Contrast 3D Ultrasound. Stanford University expects to enroll 20 research study participants.
Clinical trial: NCT02424955
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 Daniel Chang, M.D. at 650-724-3547.  
The Protocol Director may also withdraw you from the study without your consent for one or more of the following reasons:  
- Failure to follow the instructions of the Protocol Director and study staff
- Pregnancy - The study is cancelled - Other administrative reasons - 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 research use or disclosure of your health information in this study, you must write to:
Dr. Daniel Chang Associate Professor Department of Radiation Oncology Stanford University Medical Center 875 Blake Wilbur Drive CC-G231 Stanford, California 94305-5105 What Personal Information Will Be Used or Disclosed?  
Protocol Director: Daniel Chang, MD  
IRB USE ONLY  
  
Approval Date: August 11, 2021 Expiration Date: August 11, 2022
Protocol Title: Feasibility study of contrast-enhanced 3D perfusion ultrasound for liver cancer SABR planning and response evaluation Your health information related to this study may be used or disclosed in connection with this research study which may include MRN, age at onset of disease, extent of disease, current age, weight, height, therapies to date (e.g. medications, interventions), imaging information and any other information related to primary liver tumor metastases.