Clinical trial: NCT03065218
Section: Alternatives
Subsections: What Other Options Are There?

Instead of being in this study, you have these options:
- Continued active surveillance with no treatment intervention.  
- A therapy with 131I without knowing ahead of time whether or not there will be any uptake in any site of cancer or any benefit from that therapy.  
- A therapy with a tyrosine kinase inhibitor (TKI). A TKI is a drug that interferes with selected chemical processes in the cell that may or may not stabilize progressive metastatic disease.  
- You always have the option to not be in this study.
Clinical trial: NCT03065218
Section: Confidentiality
Subsections: What About Confidentiality?

Your personal health information (PHI) will be kept private to the extent allowed by law. Study records identifying you will be kept confidential and will not be made publicly available. You will not be identified by name in any publications resulting from this study. You will be asked to sign a separate form that will give permission to the investigator, representatives from government agencies, including the Food and Drug Administration (FDA), institutional review boards, the sponsor and/or the sponsor's representative(s), and certain other people, agencies or entities, to look at and review the records related to this study including your personal health information and the information discovered during this study. This separate form explains in greater detail who will have access to your records, what type of information will be reviewed  
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| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr and for what purposes, how long your permission for others to review and release your records will last, and how you may withdraw your permission if necessary. If you do not wish to sign this permission form you will not be allowed to participate in this study. A Data Safety and Monitoring Board, which is a group of experts not connected to the study, will be reviewing the data from this research throughout the study. This Data Safety and Monitoring Board is the Radioactive Drug Research Committee. We will tell you about any new information from this or other studies that may affect your health, welfare, or willingness to stay in this study.
Clinical trial: NCT03065218
Section: Duration of Study Involvement
Subsections: How Many People Will Take Part In The Study?|How Long Will I Be In The Study?

About 15 people will take part in this study, worldwide. 15 people will be recruited at this site.  
Consent To Participate In A  
MedStar Health Research  
Institute  
Clinical Research Study  
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| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr

If the 99mTc sestamibi scan does not suggest a possible source for the elevated thyroglobulin, you will be in the study one day.  
If the 99mTc sestamibi scan does suggest a possible source for the elevated serum thyroglobulin, you may be in the study for a longer period of time in order for the study doctor to follow up with you regarding further evaluation and/or treatment of the possible source of elevated serum thyroglobulin. The follow-up is part of the study and will be made over the phone at 1, 3, 6 and 12 months after the research scan and/or until diagnosis of the metastatic site. The actual evaluation and/or treatment itself for the possible source of elevated serum thyroglobulin is not part of the research study.  
The investigator may decide to take you off this study if it is believed to be in your best interest, you fail to follow instructions, new information becomes known about the safety of the study, or for other reasons the investigator or sponsor believes are important.  
You can stop participating at any time. However, if you decide to stop participating in the study, we encourage you to talk to the investigator and your regular doctor first so they can help you decide what other options may be best for your medical care once you are off study.  
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| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr If you suddenly withdraw from the study, there are no consequences, but we may not be able to use any of the information gathered from your participation.
Clinical trial: NCT03065218
Section: Participant's Rights
Subsections: What Are My Rights As A Participant?

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| Participant Initials _______                                                                           |  
| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr  
- You have the right to be told about the nature and purpose of the study;
- You have the right to be given an explanation of exactly what will be done in the study and given a description of potential risks, discomforts, or benefits that can reasonably be expected;
- You have the right to be informed of any appropriate alternatives to the study, including, if appropriate, any drugs or devices that might help you, along with their potential risks, discomforts and benefits;
- You have the right to ask any questions you may have about the study;
- You have the right to decide whether or not to be in the study without anyone misleading or deceiving you; and - You have the right to receive a copy of this consent form.
By signing this form, you will not give up any legal rights you may have as a research participant. You may choose to not take part in or to leave the study at any time. If you choose to not take part in or to leave the study, your regular care will not be affected and you will not lose any of the benefits you would have received normally. We will tell you about new information that may affect your health, welfare, or willingness to be in this study.
Clinical trial: NCT03065218
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: What Are The Risks And Side Effects Of This Study?|Are There Any Benefits To Taking Part In The Study?|What If I'M Injured Or Become Ill During The Study?

If you decide to participate in this study, you should know there may be risks. You should discuss these with the investigator and/or your regular doctor and you are encouraged to speak with your family and friends about any potential risks before making a decision. Potential risks and side effects related to this study include: Potential risks and side effects *that may occur* include:  
1. Chemical: You will receive radioactive sestamibi in very small amounts. Tracer doses do not have pharmacologic effects; however, less than 0.5 % of patients have reported the following side effects :
headache, abdominal discomfort, irregular heart beat, temporary joint pain, dizziness, vomiting, lightheadedness or fainting, allergic reaction with shortness of breath and decreased blood pressure and heart rate. Flushing, swelling, injection site inflammation, fever, itching rash and hives have also been noted.  
2. Radiation exposure: The total radiation exposure resulting from participation in this research study is estimated to be less1/100th (0.1) of the amount of radiation that you will receive if you have been or will be treated with I-131 for your thyroid cancer. In addition, the Food and Drug Administration regulates and limits the amount of radiation exposure to volunteers resulting from participating in a research study such as this to a level that it believes is acceptable. The FDA limit is 5 rem to any organ of the body for a research study such as this. The study meets the FDA requirement.  
3. Risks from blood drawing: 99mTc sestamibi will be injected into a vein in your arm using a needle as if drawing blood. Injection may cause pain and bruising and, rarely, infection at the place where the injection is performed. Sometimes the injection causes people to feel lightheaded or even faint.  
4. Claustrophobia (fear of closed spaces): Some patients have reported a feeling of claustrophobia when being imaged by a nuclear medicine camera.  
5. False positive result: This is possible if the procedure incorrectly indicates that thyroid cancer is present in a particular location or if the sestamibi appears to find a possible source for thyroglobuling but the source actually does not exists. A false positive result may result in unnecessary additional testing, biopsy and/or treatment.
Please tell the investigator about all medications including over-the-counter drugs or herbal supplements you are taking, even if you don't think they are important.  
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| Participant Initials _______                                                                           |  
| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr There may also be risks and side effects other than those listed above that we cannot predict. Many side effects go away in a short time after the injection of the 99mTc sestamibi, but, in some cases, side effects can be serious, long lasting and/or life threatening. If you have any unwanted side effects, you should ask the investigator what may be done to make the side effect less uncomfortable.  
For more information about risks and side effects, please ask Douglas Van Nostrand, MD.

You may or may not benefit in participating in this study. The 99mTc sestamibi scan may identify the source of your elevated serum thyroglobulin level that had not previously been identified by your physician or any of the other diagnostic imaging studies. This may in turn potentially allow earlier treatment of a site of cancer before that site of cancer becomes a problem to you.  
However, you may not get any direct benefit from being in this study. We cannot promise that you will experience any benefits from participating in this study. We hope the information learned from this study will benefit others in the future.

We will make every effort to prevent injuries or illness from occurring while you are in the study. In the case of an injury, illness, or other harm occurring to you during, or resulting from, the study, you should seek medical treatment. You should also contact the study doctor as soon as possible. You or your insurance company will be charged for any continuing medical care and/or hospitalization that are not a part of the study. If you suffer an injury related to the study drug or study procedures, the reasonable costs of necessary medical treatment of the injury **will not** be reimbursed by the principal investigator, MedStar Health Research Institute or MedStar Washington Hospital Center, MedStar Health or its affiliated entities to the extent these costs are not covered by your insurance or other third party coverage. No funds have been set aside, by MedStar Washington Hospital Center, the MedStar Health Research Institute, MedStar Health, or its affiliated entities to repay you in case of injury, illness, or other harm occurring during, or resulting from the study, and their current policies do not provide for payments for lost wages, cost of pain and suffering, or additional expenses. By agreeing to this you do not give up your rights to seek compensation in the courts.
Clinical trial: NCT03065218
Section: Procedures
Subsections: What Happens If I Agree To Be In The Study?

The following procedures will be done within the Division of Nuclear Medicine at MedStar Washington Hospital Center on an outpatient basis.  
Preparation: none Phase 1: You will receive an injection into your vein of a radioisotope called 99mTc sestamibi.  
Phase 2: You will wait for 60 to 90 minutes in a waiting room Phase 3: You will then be imaged lying face up on an imaging table while a camera passes around you from the top of your head to approximately the level of your knees. This requires approximately 45 minutes Phase 4: Your images will be reviewed by the nuclear medicine physician. This will take ~10-15 minutes. If additional images are required to clarify an image, then additional images of that area will be performed. As earlier, you will have the additional images performed with you lying face up. These images require ~20-45 minutes. You will then be released
- The following procedure is part of the research study and would not normally be done as part of your routine care:
- 99mTc sestamibi scan.
Clinical trial: NCT03065218
Section: Purpose of Research
Subsections: Medstar Health Research Institute Informed Consent For Clinical Research Introduction|What Is The Purpose Of This Study?

We invite you to take part in a research study called "Evaluation of 99mTc Sestamibi Scans In Patients who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies."
You were selected as a possible participant in this study because you have thyroid cancer and an elevated serum thyroglobulin level and all of your standard diagnostic imaging studies have been unable to identify the source of this elevation. Please take your time to read this form, ask any questions you may have and make your decision. We encourage you to discuss your decision with your family, friends and your doctor(s).

This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who have elevated serum thyroglobulin levels and negative diagnostic imaging tests.
Clinical trial: NCT03065218
Section: Voluntary Participation
Subsections: Who Cannot Participate In This Study?

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| Participant Initials _______                                                                           |  
| IRB Approval Stamp                                                                                  |
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| MedStar Health Research Institute APPROVAL DATE 08/28/2018 APPROVAL EXPIRES 08/29/2019 IRB APPROVED |  
Project Title:
Evaluation of 99mTc Sestamibi Scans in Patient Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies Principal Investigator: Douglas Van Nostrand **Institution:** MedStar Washington Hosp Ctr You cannot be in this study if any of the following apply to you:
- < 18 years of age,  
- Pregnant or breast feeding,
- You have not had ALL of the following diagnostic imaging scans:
- US (ultrasound), - CXR (chest-X-ray),
- CT (computer tomography scan), and
- PET scan (18F Fluoro-deoxyglucose positron emission tomography scan).  
- Any of the above diagnostic imaging scans identifying a source of the elevated serum thyroglobulin level.  
- If any of the additional diagnostic imaging scans noted below were performed and identified a source of the elevated serum thyroglobulin level
- 18F NaF PET bone scan (18F sodium fluoride positron emission tomography bone scan)
- Bone scan (
99mTc methylene diphosphonate or other equivalent bone agent )
- Brain scan (Computer tomography or magnetic resonance imaging)
- Not diagnosed with differentiated thyroid cancer