Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Phase: PHASE4
Conditions: Thyroid Cancer
Sponsor: Medstar Health Research Institute

Evaluation of 99mTc Sestamibi Scans In Patients who have Differentiated 
Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative 
Diagnostic Imaging Studies  
Principal Investigator:  
Douglas Van Nostrand, MD 
Director, Nuclear Medicine Research 
MedStar Health Research Institute and Washington Hospital Center 
Suite GA60F 
110 Irving Street, N.W. 
Washington, DC 20010 
(202) 877-0300
Add co-investigators:  
Cristiane Gomes Lima 
Research Fellow 
MedStar Health Research Institute 
Di Wu 
Research Fellow 
MedStar Health Research Institute 
Version: 06 August 2019 
Introduction 
This is a prospective, informed consent study to evaluate a diagnostic radioisotope 
scan for evaluation of a selected group of patients who have differentiated thyroid cancer, 
elevated serum thyroglobulin levels indicating the presence of disease, but negative 

diagnostic imaging studies.   The following two sections are a layman’s and medical overview 
of this study, respectively.    
Layman’s Overview 
One of the major problem areas in the management of patients who have thyroid cancer 
that is differentiated (DTC) is when their blood levels of the tumor marker for this cancer 
(thyroglobulin) increase.   Yet, despite all the efforts of the physician with physical exam and 
the standard diagnostic imaging studies, the physician is unable to find the site of metastases 
that is causing this patient’s tumor marker to increase.   
One type of scan performed with an isotope called 99mTc sestamibi was evaluated in the 
1990s and 2000s in such patients and was found useful.  However, this scan was replaced 
with multiple superior imaging modalities such as Computer Tomography (CT) scan and 18F 
fluorodeoxyglucose positron emission tomography (PET) scan.   Unfortunately, these scans 
do not always identify the site of the metastases causing the patient’s tumor marker to 
increase.   To date we are unaware of any one who has evaluated 99mTc sestamibi when all 
these other standard and extensive imaging scans are also negative.  The purpose of this 
study is to determine if 99mTc sestamibi may have a role in localizing the tumor in the patients 
who have an elevated tumor marker with all standard diagnostic scans negative. 
Medical Overview 
 
Patients who have differentiated thyroid cancer with a positive or rising serum thyroglobulin 
level (Tg) and negative standard diagnostic imaging studies (NSDIS)* or negative extensive 
diagnostic imaging studies (NEDIS)** represent a diagnostically problematic group of patients.  The 
positive or rising Tg typically indicates the presence of recurrent metastatic DTC; however, with either 
NSDIS or a NEDIS, no structural or functional recurrent or metastatic disease accounting for the 
positive or rising Tg can be identified.   As a result, potential local treatment of a specific site of 
metastases is not an option and deciding whether to continue active surveillance or to perform a 
“blind” I-131 treatment is not resolvable by the data available.     
As a result, the physicians, in order to make a management decision, must use less than 
satisfactory factors such as patient age, level of Tg, doubling time of Tg, past patient history, patient 
co-morbidities, patient desires, etc.  Accordingly, additional methods to identify the source of the 
elevated or rising Tg levels are desirable.   
 
99mTc sestamibi has been previously used in the evaluation of differentiated thyroid cancer and 
is taken up by mitochondria in differentiated thyroid cancer cells [1-11].  Although good overall 
sensitive and specificity has been shown using 99mTc sestamibi, it is not routinely used because other 
standard diagnostic imaging studies have superior sensitivity, specificity, and/or localization of DTC 
cells.  However, to our knowledge no study has been published to evaluate the utility of 99mTc 
sestamibi when the other SDCIS or EDCIS are negative.  The objective of this study is to evaluate the 
utility of 99mTc sestamibi when either all SDIS or EDIS are negative.  

*Negative STANDARD diagnostic clinical imaging studies (NSDCIS) = negative ultrasound (US), diagnostic radioiodine 
scan (DRS), chest-x-ray (CXR), computer tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose 
positron emission computer tomography scan (18F-FDG PET). 
Negative neck structural imaging at least one of the following studies, (i.e., ultrasound, CT with or without 
contrast, MRI scan) was performed and all performed imaging studies must be negative. 
Negative chest structural imaging at least one of the following studies ( i.e., x-ray, CT, MRI) must be performed, 
and all performed imaging studies must be negative. 
Negative abdominal structural imaging at least one of the following studies (i.e., ultrasound, CT, MRI) must be 
performed and all performed imaging studies must be negative. 
Negative diagnostic radioiodine whole-body scan. 
Negative FDG PET/CT scan. 
**Negative EXTENSIVE diagnostic clinical imaging studies (NEDCIS) = all of the above plus negative 18F-sodium fluoride 
positron emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone scan (99mTc MDP), 
AND negative brain CT or magnetic resonance (MR). 
OBJECTIVE OF THE STUDY 
The primary objective of this prospective study is to:  
1. Perform a pilot study of the utility of the 99mTc sestamibi scans in patients who have 
differentiated thyroid cancer, positive serum thyroglobulin levels, and negative 
SDCIS* or negative EDCIS**.    
STUDY DESIGN AND METHODS 
 
This will be a prospective informed consent study. Medical records of the patients with 
histologically documented differentiated thyroid carcinoma (DTC) in follow-up at MedStar Washington 
Hospital Center will be reviewed via the electronic medical records systems such as Centricity and 
Amalga. The subjects meeting the following eligibility criteria may be included in the study. 
INCLUSION CRITERIA 
• ≥ 18 years of age; 
• Diagnosed with differentiated thyroid carcinoma; 
• At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment, and treatment 
of distant metastases, 
• Elevated suppressed or stimulated thyroglobulin level (Tg) ≥ 5 ng/ml WITHOUT thyroglobulin 
antibodies, 
• Any measurable suppressed or stimulated thyroglobulin (Tg) level WITH positive thyroglobulin 
antibodies, 

• All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound (US), 
diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or without 
contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography scan (18F-
FDG PET) within the last 24 months. 
▪ 
Negative neck structural imaging at least one of the following studies (i.e., ultrasound, CT with or 
without contrast, MRI scan) was performed and all performed imaging studies must be negative. 
▪ 
Negative chest structural imaging at least one of the following studies (i.e., x-ray, CT, MRI) must 
be performed, and all performed imaging studies must be negative. 
▪ 
Negative abdominal structural imaging at least one of the following studies (i.e., ultrasound, CT, 
MRI) must be performed and all performed imaging studies must be negative. 
▪ 
Negative diagnostic radioiodine whole-body scan. 
▪ 
Negative 18F FDG PET/CT scan. 
 
• If EDCIS (extensive diagnostic clinical imaging studies) of 18F-sodium fluoride positron 
emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate 
bone scan (99mTc MDP), AND brain CT or magnetic resonance (MR) are performed, these 
are also negative.  
 
• OR meets all of the above prior criteria, but has stable indeterminate nodule on CT for 6 
months. Stable defined by Recist Criteria version 1.1 as “Neither sufficient shrinkage to qualify 
for partial response (30% decrease) nor sufficient increase to qualify for progressive disease 
(20% increase), taking as reference the smallest sum diameters while on study.     
EXCLUSION CRITERIA 
• < 18 years of age; 
• Pregnant or breast feeding 
• Any SDCIS or EDCIS that is positive and/or suggestive of recurrent and/or distant metastases 
secondary to DTC.  If a study is indeterminate, this will be forwarded to a committee for review and 
resolution.  
DOCUMENTATION OF PREGNANCY TESTING OR WAIVER 
Potential female subjects of childbearing age will undergo either pregnancy testing with blood 
or urine HCG levels prior to study enrollment. 
Alternatively, female subjects can opt to sign a pregnancy waiver form if she rejects 
undergoing pregnancy testing prior to study enrollment. Pregnancy waiver form will be submitted to 
the IRB for approval. 
Per Cardinal Health Sestamibi Package Insert: “Pregnancy Category C. Animal reproduction 
and teratogenicity studies have not been conducted with Technetium Tc 99m Sestamibi. It is also not 
known whether Technetium Tc 99m Sestamibi can cause fetal harm when administered to a pregnant 
woman or can affect reproductive capacity. There have been no studies in pregnant women. 
Technetium Tc 99m Sestamibi should be given to a pregnant woman only if clearly needed.” 

STUDY POPULATION:  GENDER AND ETHNIC INCLUSION 
 
No potential participants will be excluded from participating in this study solely based on 
gender, ethnic origin, or socioeconomic status.  
SUBJECT RECRUITMENT AND SCREENING 
 
The patient’s will be identified by referring endocrinologists and nuclear medicine physicians.  
For potential candidates identified from referring endocrinologists, these will be referred for screening 
through either Tasha Peterson, Dr. Di Wu, Dr. Cristiane Lima, Shari Moreau, and/or Dr. Douglas Van 
Nostrand.  Potential candidates identified by the “reading desk” nuclear medicine physician will again 
be screened by Dr. Cristiane Lima, Shari Moreau, and/or Dr. Douglas Van Nostrand.  For potential 
candidates identified by the “reading desk” nuclear medicine physician that meet the criteria, the 
referring physician will be contacted regarding our desire to speak with the patient regarding this 
study.   
After the endocrinologists supports the patient potentially participating in the study and after 
confirming that the patient passes the first screening step, the patient will be contacted to explain the 
study.  If the patient is interested, the staff will give the patient an informed consent, and then a 
discussion with the patient will follow. After final confirmation that the patient meets all inclusion 
criteria without any exclusion criteria, informed consent will be obtained.  This study is being 
submitted as an exempt study (e.g. waiver of informed consent).  
IRB APPROVAL 
 
The study will submitted to the IRB and initiated only after IRB approval of all documents 
including the protocol, informed consent and HIPPA form.  
PATIENT DATA 
The demographic, pathological, laboratory, imaging, therapy data, outcome data, etc. will be 
obtained using the electronic medical records systems such as Centricity, Amalga, and other patient 
charts such as the charts in the Division of Nuclear Medicine of MedStar Washington Hospital Center.  
Examples of data include the following:  
Demographics 
1. 
Age at diagnosis 
2. 
Gender 
 
Initial Diagnosis 
3. 
TNM at the time of diagnosis + AJCC thyroid cancer stage 
4. 
Histological type 
 
Initial Treatment 
5. 
Date of initial surgery  
6. 
Extent of initial surgery (total or subtotal) 
7. 
Histological subtype 
8. 
Post-operative Tg levels (suppressed and stimulated, when available) and thyroglobulin 
antibody 
9. 
Results of any other imaging studies including ultrasound, radioiodine scan, etc. 
10. Prescribed activity of any I-131 therapy 

11. Post I-131 therapy scan 
Six-month to one year follow-up results after initial treatment (patient history prior to sestamibi 
procedure) 
1. 
Follow up Tg levels (suppressed and stimulated, when available) 
2. 
Results of all other imaging studies including ultrasound, radioiodine scan, etc. 
Subsequent therapies 
3. 
Sequence and details of subsequent therapies. 
 
Additional information 
4. 
Number of prior I-131 therapies. 
5. 
Total cumulative prescribed activity (mCi) of I-131 received prior to the consideration of a 
“blind I-131 treatment.” 
6. 
Past imaging results (e.g. ultrasound, chest-x-ray, CT, MR, PET scan, etc.) 
7. 
Date, prescribed activity, and results of the most immediate prior I-131 therapy and post-
therapy scan.  
8. 
Results of dosimetry and dosimetric scan  
 
Performance of 99mTc Sestamibi Study. 
A. Procedure:  The following is the procedure for the 99mTc sestamibi study 
a. Intravenous injection of 20-30 mCi of 99mTc sestamibi 
b. Waiting period of approximately 1 hour 
c. Lying supine on a standard nuclear medicine gamma camera table for approximately 45 
minutes 
d. Use of parallel hole low energy collimator 
e. Acquisition time:  45 minutes 
f. Review of images by nuclear medicine physician for any extra views 
g. If necessary, either extra spot view, pinhole view, or SPECT (single photon emission 
computer tomography) image. 
h. Review of images by nuclear medicine physician. 
i. Release of patient.  
 
Radiation safety  
j. This study has been submitted to the Radiation Safety Committee 
k. Radiation Exposure:  Two routes 
i. From the 99mTc sestamibi: 
 

  
 
ii. From the low-dose localization CT of the SPECT. 
1. The PI submits that the decision by the nuclear medicine physician to 
perform an extra view, namely the SPECT-CT image, is arguably a clinical 
decision based on findings on the 99mTc sestamibi research scan.   Any 
finding on the research scan that is not initially interpreted as Grade 1 
(physiologic activity) or Grade 2 (probably physiologic activity) should be 
evaluated further based on the clinical indication to try to determine where 
this activity is precisely located in anticipation of potential treatment.   
 
However, the PI has included this in as part of the research study. 
Accordingly, there is additional radiation exposure from the low dose CT.  
The reason this is a low dose CT is because this CT is not a diagnostic CT 
but is only used for attenuation correction of the SPECT and localization of 
findings on the 99mTc sestamibi image.   When the CT is used for 
attenuation correction and localization, the exposure is significantly 
reduced from a diagnostic CT.  
 

For this study and to the estimate the percent additional radiation 
exposure to the volunteer, the data from Mhiri et al. has been used with 
the key table attached below [12] 
The percent increase of the effective dose by the inclusion of the CT is 
28%.  This is based on the 99mTc-MIBI parathyroid data above.  99mTc-MIBI 
is the abbreviation for 99mTc-sestamibi, and a CT used with 99mTc-MIBI for 
a parathyroid scan involves only one extra view.  In this case, when an 
SPECT-CT is requested by the interpreting physician for one of the 
subjects in this study, there is only one extra view.  Thus, 99mTc-MIBI 
parathyroid datum is a good surrogate for estimating the percent increase 
for a patient having a SPECT-CT in this study.  The only difference is 
instead of evaluating for possibly differentiated thyroid cancer, one is 
evaluating for parathyroid adenoma and that does not change the 
estimated increase in radiation dose.  
 
Side Effects of 99mTc sestamibi 
l. The prescribed information is attached in Appendix A. 
 
 
Contraindication of 99mTc sestamibi 
• None known per Prescribing Information. 
 
Exemption from a Sestamibi IND per 21 CFR 312.2(b) 
99mTc sestamibi is an approved FDA (Food and Drug Administration) radioisotope for the imaging of 

coronary artery disease (Cardiolite®) and breast lesions (Miraluma®). This study has no intentions to 
support a new indication or any other significant change in the labeling of the drug. There is no intention 
to support a change in the advertising for sestamibi. This study team has no intention to promote or 
commercialize sestamibi.     
The 99mTc sestamibi is commercially purchased from Cardinal Health or other available commercial 
entities that ensure labeling requirements are met. The study team does not utilize their own cyclotron to 
produce the sestamibi. The route of administration and activity (dose) of sestamibi are the same as that 
allowed in FDA indications. This study is under IRB review and patients provide signed informed 
consent prior to sestamibi scan.   
Exemption from a DSMB 
99mTc sestamibi is an approved FDA (Food and Drug Administration) radioisotope for the imaging of 
coronary artery disease (Cardiolite®) and breast lesions (Miraluma®).  Literally hundreds of thousands 
of doses have been administered, and the adverse effects are minimal and infrequent. As a result, the 
safety concerns are not unusually high and are very low.  Specifically and based on the Guidance for 
Clinical Trial Sponsors , Establishment and Operation of Clinical Trial Data Monitoring Committees, 
OMB Control No. 0910-5810, Expiration Date 12/31/2018,  there is no a priori reasons for a particular 
safety concern, no serious toxicity, no elevated risk of death/serious outcome, and the patient population 
is not fragile or vulnerable.  As a result, a DSMB not be required for this study. 
Data Safety Monitoring Plan 
 Close cooperation between the designated members of the Research Team will occur to 
evaluate and respond to individual adverse events in a timely manner.  Designated team 
members (Principal Investigator, Associate Investigators, and Study Coordinator,) will review 
the summary study safety data reports on a quarterly basis.  
I. Study Agent Accountability 
 
 Documentation  
The radiopharmacist/technologist will be responsible for maintaining an accurate record of the 
prescription number, inventory, and an accountability record of supplies for this study. 
Electronic documentation with dose manager as well as paper copies will be used.  
 Disposition  
The empty vials and the unused portion of a vial will be discarded according to the policies of 
the Radiation Safety Division of the Washington Hospital Center.   
 
II. Adverse Event Reporting 
 
a. 
Adverse Events 
An adverse event is any unfavorable or unintended change in body structure, body function or 
laboratory result associated temporally with the use of study treatment, whether or not 

considered related to the study treatment.    
b. 
Serious Adverse Events 
The term “Serious Adverse Drug Experience” is defined in 21 CFR 312.32 as follows:  “Any 
adverse drug experience occurring at any dose that results in any of the following outcomes:  
Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant disability/incapacity, or a congenital 
anomaly/birth defect.  Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered a serious adverse drug experience 
when, based upon appropriate medical judgment, they may jeopardize the subject or require 
medical or surgical intervention to prevent one of the outcomes listed in this definition.  
Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.”  
 
c. 
Adverse Event Reporting  
Information on adverse events is collected by the principal investigator and other clinic staff 
and entered into a computer database.  These data are reviewed on an ongoing basis by the 
study coordinator and the principal investigator.  Adverse experiences that meet Serious 
Adverse Event (SAE) Reporting Requirements must be reported by the clinical site to the IRB.  
 
Briefly summarized, events requiring completion of an SAE report form include the following 
and these are to be reported regardless of assessed relationship to study agent:   
• Death  
• Permanent disability/incapacity  
• Hospitalization (other than for elective reasons and the planned I-131 treatment)  
• Grade 4 adverse events  
 
In addition, any event, regardless of grade, which in the judgment of a site investigator 
represents a serious adverse event, may be reported.  
 
For the purposes of this study, a Serious Adverse Event is defined as either (1) any Grade 3 or 
Grade 4 adverse untoward event as defined by the NCI criteria and/or (2) any event, which is 
considered in the opinion of the PI to be a serious adverse event.   The PI will report SAE’s 
within seven (7) days to the IRB.   
 
The patient will be tracked for SAE’s after the administration of the tracer prescribed activity of 
sestamibi up to the time of the patient’s release after completion of sestamibi scan.   The 
Serious Adverse Events form is attached (Appendix B). 
d. 
Adverse Event Reporting to the Institutional Review Board 
 
Adverse event reporting requirements to the MHRI Institutional Review Board (IRB) for this 

protocol are as follows:  
• Investigators will submit a completed serious adverse event report to the MRI IRB within 
7 days after becoming aware of a subject death, a potentially life-threatening (grade 4) 
serious adverse event that is possibly, probably or definitely related to investigational 
agent, an inpatient hospitalization (other than elective or the I-131 treatment), a 
persistent or significant disability/incapacity, or a congenital anomaly/birth defect.    
 
• Investigators will submit a completed serious adverse event report to the MHRI IRB 
within 15 days after becoming aware of any Grade 3 (severe) adverse event that is 
possibly, probably or definitely related to investigational agent.  
 
• Investigators will report within 15 days on any other event or condition regardless of 
grade, which in their judgment represents an event reportable to the IRB.    
 
• A summary of all adverse events will be reported to the MHRI IRB with submission of a 
request for continuing review. 
 
Interpretation of 99mTc Sestamibi Study. 
A. A team of two nuclear medicine physicians will interpret the 99mTc sestamibi, and any area of 
radioactivity will be graded as by a standard nuclear medicine grading system: 
1. Normal physiological activity 
2. Probably physiological activity 
3. Indeterminate activity 
4. Probably metastatic disease 
5. Metastatic disease 
B. Criteria for “final determination” regarding whether a finding represents physiological activity or 
metastatic disease:   
a. For findings graded as 1 or 2, they will be defined for this study as physiological activity. 
b. For findings graded as 3, or 4, the following will be required: 
i. Biopsy; however, this will only be performed if clinically indicated. 
1. Follow-up:  It is anticipated that very few biopsies will be performed and 
because the criteria for entering this study is NDCIS or NECIS,  the only 
alternative for confirming whether or not a foci of 99mTc sestamibi uptake 
on a scan is metastases will be follow up, which will be performed on a 
clinical bases depending on the patient’s treating physicians’ decisions.  
The study team will follow up through telephone at 1, 3, 6 and 12 months 
after the sestamibi scan and/or until diagnosis of the metastatic site.  The 
purpose of the telephone follow-up is to enquire on what, if any, blood 
tests, imaging studies or biopsies were ordered by the patient’s treating 
physician. However, if on follow up any of the following occur, then the 
focus will be categorized as a metastases (true positive).  
a. Subsequent biopsy, 

b. Subsequent clinical imaging study(s) (For example, although a lytic 
bone lesion in the area of interested was not present initially on the 
CT, a lytic lesion indicative of metastases may subsequently 
develop in that area, and for this study this will be defined  as 
evidence of metastases of DTC (true positive).   
 
ii. Blind I-131 treatment** with or without a prefatory scan:   If a “blind” I-131 
treatment” is clinically selected and the post I-131 therapy scan demonstrates 
uptake in the same areas as the 99mTc sestamibi, then the finding on the 99mTc 
sestamibi will be classified for this study as a metastases of DTC.  
  
c. Grade 5 is not anticipated, because unlike I-131, which can have patterns that are very 
specific for DTC, 99mTc sestamibi patterns are not specific for DTC.  
 
** A “blind I-131 treatment” is a potential therapeutic option, and this term means 
that the treating physician or team cannot identify the source of the patient’s 
elevated Tg, but because of factors such as the level of elevated Tg, the rate of 
rise of the Tg, and the patient’s clinical situation, a therapeutic administration of I-
131 is give despite being “blind” to the source of the Tg.   
Patient Numbers 
a.  As noted in the objective of this study, this is a pilot study.  As a pilot study, the present 
plan is to perform 15 patients.  If no findings of Grade 3, 4, or 5 are identified on the first 
fifteen 99mTc sestamibi scans, then the study will be terminated.   
b. If Grade 3, 4, or 5 findings are observed, then the study will continue with the follow-up 
of those patients with those findings to determine as best as reasonably possible 
whether or not the findings represent metastatic disease from DTC.  However, no 
further patients will be recruited for 99mTc sestamibi scanning until that data become 
available and reviewed.  
c. At this time, I am unable to establish what would be criteria to reinitiate 99mTc sestamibi 
scanning or completely terminate the study. 
Statistical analysis:   
1. I have initiated a conversation with Mihriye Mete regarding what additional statistical analysis 
may be reasonable for such a pilot study. 
PROJECT ORGANIZATION 
Organizational Flowchart 
 

 
• An authorization chart delegating various functions is being developed. 
Project timetable  
 
DATA HANDLING AND RECORD KEEPING 
Confidentiality 
 
The Principal Investigator will ensure that subjects’ anonymity is maintained. Subjects will not 
be identified in any reports on this study. All records will be kept confidential to the extent required by 
federal, state and local law.   
Study Documentation and Storage 
 
The Principal Investigator is responsible for maintaining a comprehensive and centralized filing 
system of all study-related (essential) documentation, suitable for inspection at any time by 
representatives from the MHRI, IRB, FDA, and/or applicable regulatory authorities.  
 
In addition, all original submission documentation will be maintained and be readily available at 
InfoEd. All essential documentation should be retained by the institution for the same period of time 
required for medical records retention. No study document should be destroyed without prior written 
agreement between the MHRI and the Principal Investigator. Should the investigator wish to assign 
the study records to another party or move them to another location, MHRI must be notified in writing 
of the new responsible person and/or the new location. 
 
All data will be coded, and the data and the code document will be on computer in a secure file 
with password on a secure computer with password. 
Problems/weaknesses:  The very nature of this study in regard to inclusion criteria, namely negative 
standard or extensive clinically diagnostic imaging scans, is problematic in determining “truth” 
regarding whether or not a foci of 99mTc sestamibi is secondary to metastatic DTC.  But that problem 
should not stop one from performing such a study evaluation for these problematic patients.  
• Oversee the entire study. 
Douglas Van Nostrand, MD
Principal Investigator
•Responsible for IRB Forms/ Submission
•Data collection
Di Wu, MD
Co-Investigator
• Responsible for IRB Forms/ Submission
• Data collection
Cristiane Gomes Lima, MD
Co-Investigator
August
Submit protocol to 
IRB
October
Obtain IRB approval 
and start gathering 
data
December
Preliminary partial 
data collection with 
submission of 
abstract
March 2017
Completion of 
data acquisition 
with subsequent 
analysis. 

Risk/Benefit Assessment:  The risk/benefit assessment for this study is very low.  The risk of side 
effects is typically <1%, and if they occur they are minor.   The likelihood of benefit is not known and 
is the objective of the study; however, if the source of the patient’s elevated serum thyroglobulin is 
identified, this could have significant potential benefit because of the potential for earlier treatment 
and avoidance of complications from the site of metastases later.    
Study Population-Gender/Ethnic Inclusion:  The selection of the study population is not based on 
gender or ethnicity.    
 
Data Management: As noted above, confidentiality will be maintained by coding each patient, and all 
of the patient's identifiers will be stored on the principal investigator’s computer in which the file and 
the computer are password protected.  
 
Subject Identification: All patients will be identified in the Division Nuclear Medicine at the MedStar 
Washington Hospital Center.   
 
Participation of Children:  Children of less than 18 years of age are not eligible to participate in this clinical 
trial.   
 
Compensation Plan for Subjects:  None 
 
Informed Consent:  Attached 
 
Vertebrate Animals: Not applicable 
 
Consultants—None 
 
Budget: 
 
 
The work will be performed by Douglas Van Nostrand (DVN) and Cristiane Lima (CL) and 
subsequently Di Wu (DW), future research assistant, who will be added to the study on arrival.   DVN 
works without salary or compensation and Cl’s and DW’s salary will be paid from the research fund 
for thyroid cancer research. 
 
 
For expenses related to abstract submission, poster presentation, travel for presentations, etc. 
will be paid from the research fund for nuclear medicine thyroid cancer. 
 
For the 99mTc Sestamibi radioisotope and scan, per Wayne Dunkle, the expense is $295.94 
for the 78801 scan code, which includes 99mTc tetrafosmin.   Because we will be using 99mTc 
sestamibi, there is an additional $10.00 surcharge.   
 
 
 
Item 
Charge 
Units 
Subtotal 
78801 scan 
$295.94 
15 
$4439.10 
Surcharge for 99mTc Sestamibi 
$10 
15 
$150.00 
Poster preparation, travel, lodging for 
$1900 
1 
$1900 

Presentation of initial results 
Poster preparation, travel, lodging for 
Presentation of final results 
$1900 
1 
$1900 
Manuscript preparation and submission 
including journal fees, etc.  
$1800 
1 
$1800 
Statistical analysis and support 
$1500 
1 
$1500 
Miscellaneous expenses 
 
 
$1200 
Cristiane Lima 
 
 
Salary already 
covered  
Di Wu 
 
 
Salary already 
covered  
D Van Nostrand 
 
 
Pro bono  
 
  
 
Appendices 
 
Appendix A:  Prescribing Information, which will be uploaded separately to InfoEd. 
 
Appendix B:  Adverse events form. 
 

 
 

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