Elastography in Thyroid Nodule Evaluation
Phase: NA
Conditions: Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule
Sponsor: Stanford University

 
 
 
 
TITLE 
Elastography in Thyroid Nodule Evaluation 
 
 
 
Protocol Director  
Aya Kamaya, MD 
300 Pasteur Drive 
Stanford, CA 94305 
kamaya@stanford.edu 
 
Co-Investigators 
Juergen K. Willmann, MD 
300 Pasteur Drive, 
Stanford, CA 94305 
willmann@stanford.edu 
 
Co-Investigators 
Terry Desser, MD 
300 Pasteur Drive, 
Stanford, CA  94305 
desser@stanford.edu 
 
L. Chris Holsinger, MD 
900 Blake Wilbur Dr 
Stanford, CA 94305 
 
 
John Sunwoo, MD 
875 Blake Wilbur Dr 
Stanford, CA 94305 
 
 
Jing Ning 
jning@stanfordhealthcare.org 
 
 
Data Manager 
Krithika Rupnarayan 
 
 
 
 
 
 
NCT03174925 
SRC Approved Protocol / Version 1 / Version Date 04-03-2017 
 
 
Biostatistician 
Lu Tian, PhD 
Dept of Health Research and Policy 

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Stanford University School of Medicine 
Palo Alto, CA 94305 
lutian@stanford.edu 
 
Study Coordinator 
Divya Pathak 
CCTO, 800 welch road 
Palo Alto, CA 94304 
 
 
 
SRC Approved Protocol / Version 1 / Version Date 04-03-2017 

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TABLE OF CONTENTS 
 
  
Table of Contents 
1. 
OBJECTIVES ............................................................................................................................................ 6 
1.1. 
Primary Objective .............................................................................................................................. 6 
1.2. 
Secondary Objectives ..................................................................................................................... 6 
2. 
BACKGROUND ........................................................................................................................................ 6 
2.1. 
Study Disease ..................................................................................................................................... 6 
2.2. 
Study Agent/Device/Imaging procedure ................................................................................. 6 
2.3. 
Clinicaltrials.gov ................................................................................................................................ 6 
2.4. 
Rationale ............................................................................................................................................... 6 
2.5. 
Preliminary results ............................................................................................................................ 7 
2.6. 
Study Design ....................................................................................................................................... 7 
3. 
PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES ...................................... 7 
4. 
IMAGING AGENT/DEVICE/PROCEDURE INFORMATION ..................................................... 8 
4.1. 
Name of Study Agent/Device/Imaging Procedure ............................................................... 8 
5. 
STUDY PROCEDURES ......................................................................................................................... 8 
5.1 
Criteria for Removal from Study ................................................................................................. 8 
    5.2       Alternatives 
6. 
STUDY CALENDAR ............................................................................................................................... 8 
7. 
ADVERSE EVENTS AND REPORTING PROCEDURES ....................................................... 10 
7.1. 
Potential Adverse Events............................................................................................................ 10 
7.2. 
Adverse Event Reporting ............................................................................................................ 10 
8. 
REGULATORY CONSIDERATIONS ............................................................................................. 10 
8.1. 
Institutional Review of Protocol ............................................................................................... 10 
8.2. 
Data Management Plan ................................................................................................................ 10 
8.3. 
Data and Safety Monitoring Plan ............................................................................................. 10 
9. 
MEASUREMENTS ................................................................................................................................ 11 
9.1. 
Primary and Secondary Outcome measures ..................................................................... 11 
9.2. 
Measurment methods ................................................................................................................... 11 
9.3. 
Measurement Time Points .......................................................................................................... 11 
9.4. 
Response Review ........................................................................................................................... 11 
9.5. 
Secondary Outcome ..................................................................................................................... 11 
10. 
STATISTICAL CONSIDERATIONS ........................................................................................... 11 
10.1. 
Statistical Design ....................................................................................................................... 11 
10.2. 
Randomization ............................................................................................................................ 11 
10.3. 
Interim analyses ......................................................................................................................... 11 
10.4. 
Descriptive Statistics and Exploratory Data Analysis ............................................... 11 
10.5. 
Primary Analysis ........................................................................................................................ 11 
10.6. 
Secondary Analysis .................................................................................................................. 12 
10.7. 
Sample Size .................................................................................................................................. 12 
10.8. 
Accrual estimates ...................................................................................................................... 12 
10.9. 
Criteria for future studies ....................................................................................................... 12 
11. 
REFERENCES .................................................................................................................................. 12 
Appendix A:  Inclusion/Exclusion Criteria Checklist .................................................................... 14 
 

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MA 
  
 
 
Patient is 
identified
Patient is 
identified
•Patient has thyroid nodule
•Identified from the Ultrasound Schedule
•Invited to participate
Consented
Consented
•Scheduled for Standard of Care Ultrasound 
•Patient fits inclusion and exclusion criteria 
•Over the age of 18.
•Understands the nature of the study and are willing to participate
Imaged
Imaged
•Standard of Care B-mode Ultrasound
•Elastography sonogram – additional 5-10 minutes
Schema 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS  
 
CBC 
Complete blood count 
CI 
Confidence interval 
CMAX 
Maximum concentration of drug 
CNS 
Central nervous system 
CRF 
Case report/Record form 
CR 
Complete response 
CSM 
Conventional Staging Method 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLT 
Dose Limiting Toxicity 
DSMB 
Data Safety Monitoring Board 
ECG 
Electrocardiogram 
ECOG Performance Status 
Easter Cooperative Oncology Group Performance Status 
EFS 
Event Free Survival 
FDG 
Fluorodeoxyglucose 
GI 
Gastrointestinal 
Hgb 
Hemoglobin 
HIV 
Human Immunodeficiency Virus 
HPF 
High-power field  
HTN 
Hypertensions 
IPI 
International Prognostic Index 
IRB 
Institutional Review Board 
IV 
Intravenous 
LLN 
Lower limit of normal  
NHL 
Non-Hodgkin’s Lymphoma 
NPV 
Negative Predictive Value 
OS 
Overall survival  
PET/CT 
Positron emission tomography – computed tomography 
PLT 
Platelet 
PD 
Progressive diseased 
PPV 
Positive Predictive Value 
PFS 
Progression free survival  
PR 
Partial response 
QD 
Once daily 
RECIST 
Response evaluation criteria in solid tumors 
RM 
Residual Mass 
ROC 
Receiver-Operative-Characteristic 
RR 
Response rate 
SAE 
Serious adverse event 
SD 
Stable disease 
SUV 
Standard Uptake Value 
TTP 
Time to progression 
ULN 
Upper limit of normal 
UNK 
Unknown 
 
 
 

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1. OBJECTIVES 
 
1.1. Primary Objective  
The purpose of this study is to determine the utility of ultrasound elastography in evaluation 
of thyroid nodules. Elastography is a non-invasive method in which stiffness or strain images 
of soft tissues are used to characterize a nodule or mass lesions. Tissue that is more stiff is 
thought to have a greater risk of malignancy. 
 
1.2. Secondary Objectives 
 
 No secondary objective. 
 
2. BACKGROUND 
 
2.1. Study Disease 
Patients with thyroid nodules will be studied.  
 
2.2. Study Agent/Device/Imaging procedure 
 
Patients are not given a treatment or imaging agent. They are having a procedure - an 
Elastography Ultrasound (experimental) as well as a standard of care ultrasound.  
 
 
2.3. Clinicaltrials.gov  
This investigation does not require an Investigational New Drug application (IND). 
 
2.4. Rationale 
 
Thyroid nodules are extremely common, affecting nearly half of the adult population. 
Although extremely common, a minority, between 1.5 – 10% of thyroid nodules, are 
malignant. [1] Differentiation between benign and malignant nodules however, based on 
physical examination and ultrasound imaging is very difficult and generally is referred 
for invasive percutaneous biopsy or surgical excision for definitive diagnosis.  
 
Because of the very common occurrence of thyroid nodules in the general public, there is a 
great need for a noninvasive means of stratifying those who are at greater risk of 
malignancy from those who are more likely to harbor a benign nodule for which no treatment 
is necessary.  
 
Recent studies have examined elastography in thyroid nodules with findings of high 
sensitivity and good specificity. [2] Other investigators have looked at elastography in 
evaluation of other  [3] [4] It is thought that lesions that are stiffer are more likely to represent 
malignancy or other pathology than benign or normal tissue which tend to be more softer.  
 
Elastography is a noninvasive ultrasound technology which can evaluate the stiffness of a 
lesion compared to the background tissue. There are two major methods of measuring 
stiffness: strain imaging, and shear wave velocity measurement. In strain imaging, 
ultrasound maps the relative tissue deformity by extrinsic compression and provides a color 
map. Greater deformation with pressure corresponds to more elastic tissue and less 
deformation corresponds to stiffer tissue. In the second method, shear waves are sent 
through a given volume of tissue and the speed of the shear wave propagation is measured. 
Since stiffer tissues have higher shear wave velocities, this can be correlated with tissue 

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stiffness to provide a more quantative measurement. Velocities can then be used to 
calculate Young modulus in kPa. [5] 
 
Most shear wave elastography measurements currently available use a single point 
measurement; however, a new 2-D shear wave elastography measurement technique will 
be used in our study to measure stiffness of thyroid nodules. This will allow sampling of a 
larger area of a nodule instead of just one point, which may be more representative of the 
nodule’s overall stiffness.  
 
 
 
2.5. Preliminary results 
Preliminary results show that the stiffness or elastography values of malignant nodules tend to be 
greater than benign thyroid nodules.  
 
2.6. Study Design 
• 
Single Group 
 
• 
There will be one intervention arm 
 
• 
The study will be open: no masking is used  
 
• 
The study is not randomized 
 
 
3. PARTICIPANT SELECTION AND ENROLLMENT PROCEDURES 
 
3.1. Inclusion Criteria 
  
3.1.1. Age greater than or equal to 18 years. 
 
3.1.2. Presence of a thyroid nodule that is amenable to ultrasound guided fine needle 
aspiration. 
 
 
3.2. Exclusion Criteria 
 
3.2.1.  Patients younger than 18 
  
3.2.2. Patients who are unable to lie supine for a biopsy. 
 
3.2.3. Pregnant patients 
 
 
3.3. Informed Consent Process 
 
All participants must be provided a consent form describing the study with sufficient 
information for participants to make an informed decision regarding their participation.  
Participants must sign the IRB approved informed consent prior to participation in any study 
specific procedure. The participant must receive a copy of the signed and dated consent 

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document.  The original signed copy of the consent document must be retained in the 
medical record or research file.  
 
3.4. Randomization Procedures 
This is an open label study, therefore patients will not be randomized. 
 
3.5. Study Timeline 
 
3.5.1. Primary Completion: 
      The study will reach primary completion 36 months from the time the study opens to 
accrual. 
 
3.6. Study Completion: 
The study will reach study completion 36 months from the time the study opens to accrual. 
 
 
4. IMAGING AGENT/DEVICE/PROCEDURE INFORMATION 
 
4.1. Name of Study Agent/Device/Imaging Procedure 
 
No imaging agent will be used in this study. 
 
• 
The examination will consist of an ultrasound elastography assessment in which an 
ultrasound machine is used to evaluate elastography measurements of a thyroid 
nodule.  
• 
Each patient will undergo one ultrasound elastography assessment of the thyroid 
prior to either fine needle aspiration or surgical resection of the thyroid nodule 
(invasive procedure is not part of the study)  
• 
No radiation will be used for this examination. Ultrasound is an imaging modality that 
uses sound waves, not radiation in imaging.  
• 
Ultrasound machines are FDA approved.  
 
 
5. STUDY PROCEDURES  
5.1 Criteria for Removal from Study 
After patient has ultrasound elastography of the thyroid nodule, they will have completed the 
study. If the patient cannot lie still in supine position then they will be removed from the 
study.  
 
5.2 Alternatives 
Alternative is to not participate in the study and continue with planned standard of care 
ultrasound and/or fine needle aspiration of thyroid nodule.  
 
6. STUDY CALENDAR 
 
   
Pre-Study 
Procedure- post 
consent 
 
Investigational Agent 
 
 
 
 

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Informed consent 
 
X 
 
 
 
Radiologic evaluation 
(ultrasound) 
 
 
 
X  
 

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7. ADVERSE EVENTS AND REPORTING PROCEDURES 
 
7.1. Potential Adverse Events 
There are no known side effects or adverse events from elastography. However, if any are   
detected, they will be reported. 
 
7.2. Adverse Event Reporting 
 
 No adverse events are expected to occur in this study. 
 
Adverse events will be graded according to CTCAE v4.0.  Both Serious and Non-Serious 
Adverse Events will be clearly noted in source documentation and listed on study specific 
Case Report Forms (CRFs).  The Protocol Director (PD) or designee will assess each 
Adverse Event (AE) to determine whether it is unexpected according to the Informed 
Consent, Protocol Document, or Investigator’s Brochures, and related to the investigation. 
All Serious Adverse Events (SAEs) will be tracked until resolution and 30 days after the last 
dose of the study treatment.  
 
8. REGULATORY CONSIDERATIONS 
8.1. Institutional Review of Protocol 
 
 
The protocol, the proposed informed consent and all forms of participant information related 
to the study (e.g. advertisements used to recruit participants) will be reviewed and approved 
by the Stanford IRB and Scientific Review Committee (SRC).  Any changes made to the 
protocol will be submitted as a modification and will be approved by the IRB and SRC prior 
to implementation.  The Protocol Director will disseminate the protocol amendment 
information to all participating investigators. 
 
8.2. Data Management Plan 
Data will be stored in Oncore and REDCap. Other data will be stored on a password 
protected and encrypted computer or on a HIPAA compliant server through Stanford, BOX.  
 
8.3. Data and Safety Monitoring Plan 
 
During the clinical investigation, the Protocol Director will evaluate the progress of the trial, 
including periodic assessments of data quality and timeliness, participant recruitment, 
accrual and retention, participant risk versus benefit, and other factors that can affect study 
outcome.  
 
The Stanford Cancer Institute Data and Safety Monitoring Committee (DSMC) will audit 
study related activities at least annually in accordance with the DSMC SOP to determine 
whether the study has been conducted in accordance with the protocol, local standard 
operating procedures, FDA regulations, and Good Clinical Practice (GCP).  This may 
include review of regulatory binders, case report forms, eligibility checklists, and source 
documents.  In addition, the DSMC will regularly review serious adverse events and protocol 
deviations associated with the research to ensure the protection of human subjects.  Results 
of DSMC audits will be communicated to the IRB and the appropriate regulatory authorities 
at the time of continuing review, or in an expedited fashion, as needed. 
 

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9. MEASUREMENTS 
9.1. Primary and Secondary Outcome measures 
Elastography shear wave velocity measurements of thyroid nodules will be compared to fine 
needle aspiration biopsy results or surgical pathologic specimens, if available.  
No secondary outcome measurements will be made.  
 
 
9.2. Measurement methods      
Elastography shear wave velocity measurements of thyroid nodules (which are calculated 
by the ultrasound machine at the time of the elastography measurements) will be compared 
to fine needle aspiration biopsy results or surgical pathologic specimens, if applicable.  
 
9.3. Measurement Time Points 
Elastography shear wave velocity measurements of thyroid nodules will be compared to fine 
needle      aspiration biopsy results or surgical pathologic specimens, if applicable. No 
follow-up imaging or assessment will be required.  
 
9.4. Response Review 
No response review is planned. 
 
9.5. Secondary Outcome 
There is no secondary outcome. 
 
10. STATISTICAL CONSIDERATIONS 
10.1. 
Statistical Design 
This is a prospective single arm blinded study in which patients who come for biopsy or 
surgical resection will be analyzed with elastography prior to biopsy or surgical resection. A 
sample size of 10 vs 43 provide 80% power for detecting a difference of 0.84 m/sec at the 
significance level of 0.05 based on Wilcoxon rank sum test assuming that the sound velocity 
for benign (and malignant nodules) follows a Gaussian distribution).  The standard deviation 
is 0.79 meters/second based on the observed standard deviation from our pilot data.  
 
We propose to use Wilcoxon rank sum test for its robustness in cases where the velocity does 
not follow the Gaussian distribution. Even if the Gaussian assumption is true, the Wilcoxon 
rank sum test is almost as powerful as the parametric t-test.  
 
Randomization 
Patients are not randomized in this study. 
 
10.2. 
Interim analyses 
There will not be a statistical stopping rule. Every three months, the data collected will be 
analyzed and a record of the monitoring activities wil be maintained by the study team.  
 
10.3. 
Descriptive Statistics and Exploratory Data Analysis 
 The distribution of the elastography measurements will be summarized by mean and 
standard deviation. If the distribution is highly non-Gaussian, then median and other 
quantiles will be provided as well.  The summaries will be provided by malignancy status.   
 
10.4. 
Primary Analysis  
The primary analysis will be a comparison of tissue stiffness measured by the sound 

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velocity between malignant and benign nodules.  To this end, the two-sided two sample 
Wilcoxon rank sum test will be used and the statistical significance level is 0.05. 
 
10.4.1. Analysis Population 
                        Analysis population is 53 patients expected to consist of 10 cancer patients and 
43 non-cancer patients. 
 
 
10.4.2. Analysis Plan 
Appropriate summary statistics will be provided for the sound velocity by the malignancy 
status.  two-sided two sample Wilcoxon rank sum test will be used to compare of tissue 
stiffness measured by the sound velocity between malignant and benign nodules 
 
 
10.5. 
Secondary Analysis 
NA. 
 
10.5.1. Analysis Population 
 
NA 
10.5.2. Analysis Plan 
 
NA 
 
10.6. 
Sample Size 
       53 patients 
 
10.7. 
Accrual estimates 
 
 
We expect to accrue 53 patients over 3 years. 
 
10.8. 
Criteria for future studies 
 
If current study yields promising results, a larger study may be performed with utilization of 
other types of ultrasound elastography measurements. Since elastography measurements may 
vary between ultrasound machines as well as different elastography techniques, it will be 
important to understand which technique yields the most reliable and consistent results.  
 
 
11. REFERENCES 
 
 
 
1. Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med 2004;351:1764-1771 
2. Bojunga J, Herrmann E, Meyer G, Weber S, Zeuzem S, Friedrich- Rust M. Real-time elastography for 
the differentiation of benign and malignant thyroid nodules: a meta-analysis. Thyroid;20:1145-1150 
3. Cosgrove DO, Berg WA, Dore CJ, et al. Shear wave elastography for breast masses is highly 
reproducible. Eur Radiol. 2012 May;22(5):1023-32 
 
4. Bhatia KS, Cho CC, Tong CS, Lee YY, Yuen EH, Ahuja AT. Shear wave elastography of focal salivary 
gland lesions: preliminary experience in a routine head and neck US clinic. Eur Radiol 2012 
May;22(5):957-65 

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5. Kamaya A, Machtaler S, Safari Sanjani S, Nikoozadeh A, Graham Sommer F, Pierre Khuri-
Yakub BT, Willmann JK, Desser TS. New technologies in clinical ultrasound. Semin 
Roentgenol. 2013 Jul;48(3):214-23  
 
  
 

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Appendix A:  Inclusion/Exclusion Criteria Checklist 
 
 
IV.  Statement of Eligibility 
This subject is [ 
 eligible / 
 ineligible ] for participation in the study. 
 
 
Signature: 
Date: 
Printed Name: 
 
Signature: 
Date: 
Printed Name: 
Signature: 
Date: 
Printed Name: 
 
 
Inclusion Criteria 
(From IRB approved protocol) 
Yes 
No 
Supporting Documentation* 
1. 
Patient is ≥ 18 years old at the time of the 
participation 
 
 
      
2. 
Presence of a thyroid nodule  
 
 
      
Exclusion Criteria 
(From IRB approved protocol) 
 
1. 
Patients younger than 18 
 
 
      
2. 
Patients who are unable to lie supine for a 
biopsy 
 
 
      
3. 
Pregnant Patients 
 
 
      

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Are you participating in any other research studies? _____ Yes _____No 
 
PURPOSE OF RESEARCH 
 
You are invited to participate in a research study of ultrasound elastography of thyroid 
nodules.  We hope to learn whether elastography is an effective technique for imaging 
nodules in the thyroid. You were selected as a possible participant in this study because 
you have a thyroid nodule that will be biopsied.    
 
This research study is looking for 50 patients with thyroid nodules being seen at 
Stanford University Hospital Department of Radiology for a thyroid biopsy. Stanford 
University expects to enroll 50 research study participants. 
 
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.  If you wish to participate in 
this study, you must sign this form. 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.  
 
If you decide to terminate your participation in this study, you should notify Dr. Aya 
Kamaya at xxx-xxx-xxxx. 
 
DURATION OF STUDY INVOLVEMENT  
 
Your participation in this research study is expected to take approximately 15 minutes, 
with screening of each participant taking approximately 5 minutes, and elastography 
imaging taking less than 10 minutes. The duration of the entire study is expected to 
take approximately three years, including time for data analysis. 
 
PROCEDURES 
 
If you choose to participate, Dr. Kamaya or a designated representative from her 
research study staff will describe the procedure to you before performing an ultrasound 
elastography study of your thyroid.  
 
Though ultrasound has been used routinely in hospitals for decades, we are studying 
the effectiveness of ultrasound elastography, which is an experimental imaging study. 
The ultrasound elastography imaging study will take less than 10 minutes, and will 
involve using a special ultrasound machine with elastography capabilities.  Elastography 
measurements will be obtained, which measures the degree of compressibility of the 
thyroid nodule compared to background thyroid tissue.  There is no ionizing radiation 
involved with elastography and there is no known side effect of elastography imaging.    

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IF YOU FEEL DISCOMFORT AT ANY TIME, NOTIFY THE OPERATOR AND YOU 
CAN DISCONTINUE THE EXAM AT ANY TIME. 
 
PARTICIPANT RESPONSIBILITIES           
 
As a participant, your responsibilities include:  
• Follow the instructions of the Protocol Director and study staff. 
• Ask questions as you think of them. 
• Tell the Protocol Director or research staff if you change your mind about staying 
in the study. 
 
WITHDRAWAL FROM STUDY 
 
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.  You may withdraw at any time 
by verbally indicating your desire to withdraw. 
 
If you decide to withdraw your consent to participate in this study, you should notify Dr. 
Aya Kamaya at xxx-xxx-xxxx.  
 
The Protocol Director may also withdraw you from the study 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 study is cancelled;  
o Other administrative reasons; 
o Unanticipated circumstances. 
 
POSSIBLE RISKS, DISCOMFORTS, AND INCONVENIENCES  
 
• 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 be expected to lie still during the ultrasound elastography study for 
approximately 10 minutes, which may be uncomfortable. 
 
 
 
POTENTIAL BENEFITS                              
 

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This study may result in the acquisition of important knowledge that may benefit future 
patient management; however, we cannot and do not guarantee or promise that 
you will receive any benefits from this study. 
 
ALTERNATIVES 
 
The alternative to voluntary participation is not to participate.  
 
PARTICIPANT’S 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. 
 
CONFIDENTIALITY 
 
Your identity will be kept as confidential as possible as required by law.  Except as 
required by law, you will not be identified by name, social security number, address, 
telephone number, or any other direct personal identifier.  Your research records may 
be disclosed outside of Stanford, but in this case, you will be identified only by a unique 
code number.  Information about the code will be kept in a secure location and access 
limited to research study personnel.   
 
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. 
 
ClinicalTrials.gov 
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. 
 
 

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Authorization to Use Your Health Information for 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.   
 
What is the purpose of this research study and how will my health 
information be utilized in the study? 
The purpose of your participation in this study is the evaluation and optimization 
of ultrasound elastography techniques for thyroid nodule imaging.  Technical 
evaluation of your scans will allow determination of the best techniques for 
ultrasound elastography imaging of thyroid nodules.   
 
Do I have to sign this authorization form? 
You do not have to sign this authorization form.  But if you do not, you will not be 
able to participate in this research study. Signing the form is not a condition for 
receiving any medical care outside the study. 
 
If I sign, can I revoke it or withdraw from the research later? 
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 notify 
Dr. Kamaya in writing at 300 Pasteur Drive, H1307, Stanford, CA 94305-5105. 
 
What Personal Information Will Be 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 name, 
medical record number, age, imaging information and any laboratory or clinical 
information related to the thyroid nodule.  
 

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Who May Use or Disclose the Information? 
The following parties are authorized to use and/or disclose your health information 
in connection with this research study: 
• The Protocol Director, Dr. Aya Kamaya 
• 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 
• Siemens Inc.   
• The Food and Drug Administration 
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. 
 
When will my authorization expire? 
Your authorization for the use and/or disclosure of your health information will 
expire on December 31, 2058 or when the research project ends, whichever is 
earlier. 
 
 
__________________________________   
 
___________________                        
Signature of Adult Participant   
 
 
Date & Time 
 
 
___________________________________ 
Print Name of Adult Participant 
 
 
 
 
 
 
 
FINANCIAL CONSIDERATIONS 
 

Protocol Document Template for Cancer Imaging Trials  
Version 2 
 
Version #1, Date 04/03/2017 
Page 21 of 22 
CONFIDENTIAL 
Payment: You will not be paid to participate in this research study. 
 
 
Costs: There is no cost to you for participating in this study. 
 
Sponsor: Siemens Medical Solutions USA, Inc.is providing financial support and/or 
material for this study. 
 
COMPENSATION for Research-Related Injury 
 
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, 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. 
 
CONTACT INFORMATION  
 
Questions, Concerns, or Complaints:  If you have any questions, concerns or complaints 
about this research study, its procedures, risks and benefits, or alternative courses of 
treatment, you should ask the Protocol Director, Dr. Kamaya.  You may contact her now 
or later at xxx-xxx-xxxx. You should also contact her at any time if you feel you have 
been hurt by being a part of this study. 
 
Independent Contact:  If you are not satisfied with how this study is being conducted, 
or if you have any concerns, complaints, or general questions about the research or 
your rights as a participant, please contact the Stanford Institutional Review Board 
(IRB) to speak to someone independent of the research team at (xxx)-xxx-xxxx or toll 
free at 1-xxx-xxx-xxxx.  You can also write to the Stanford IRB, Stanford University, 
3000 El Camino Real, Five Palo Alto Square, Palo Alto, CA 94306. 
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS 
 

Protocol Document Template for Cancer Imaging Trials  
Version 2 
 
Version #1, Date 04/03/2017 
Page 22 of 22 
CONFIDENTIAL 
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. 
  
 
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 & Time 
 
___________________________________ 
Print Name of Adult Participant 
 
________________________________ 
Signature of Person Obtaining Consent  
________________ 
Date & Time 
 
___________________________________ 
Print Name of Person Obtaining Consent