Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Conditions: Breast Neoplasm Female, Cancer, Breast, Thermography
Sponsor: First Sense Medical, LLC

 
Proprietary and Confidential 
The information in this document is considered privileged and confidential, and may not be disclosed to others except 
to the extent necessary to obtain Institutional Review Board approval and informed consent, or as required by 
Federal and State laws.  Persons to whom this information is disclosed should be informed that this information is 
privileged and confidential and that it should not be further disclosed. 
Protocol Title: Thermalogical Analysis of a cohort of women undergoing mammographic analysis. 
 
Protocol Number:  SBS-001 
Version Number:  1 
Version Date:  6/28/2017 
Contact Information 
Principal Investigator  
Dr. Haitham Elsamaloty 
University of Toledo 
3000 Arlington Ave, Toledo OH 43614 
Telephone: 419-383-3428 
E-mail:haitham.elsamaloty@utoledo.edu 
Study Sponsor 
John Rush CEO 
First Sense Medical, LLC 
2001 Centerpoint Parkway, Suite 110, Pontiac, MI 48341 
Telephone: 248-444-1492 
Email: pgangott@firstsensemed.com 
 
Clinical Research Coordinator 
Stephanie Jo Smiddy 
Eleanor N. Dana Cancer Center  
3000 Arlington Ave 
Toledo, OH 43614 
Telephone:  (419) 383-6962 
Email: Stephanie.Smiddy@utoledo.edu 

 
Version date: 6/28/2017 
 
 
 
 
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Protocol Signature Page 
Protocol No: SBS-001 
Version Date: 6/28/2017 
1. I agree to follow this protocol version as approved by Schulman and Associates IRB. 
2. I will conduct the study in accordance with applicable IRB requirements, Federal regulations, and 
state and local laws to maintain the protection of the rights and welfare of study participants.  
3. I certify that I, and the study staff, have received the requisite training to conduct this research 
protocol.  
4. I have read and understand the information in the Investigators’ Instructions for Use regarding the 
risks and potential benefits. I agree to conduct the protocol in accordance with Good Clinical 
Practices (ICH-GCP), the applicable ethical principles, the Statement of Investigator (Form FDA 
1572), and with local regulatory requirements. 
5. I agree to maintain adequate and accurate records in accordance with IRB policies, Federal, state 
and local laws and regulations. 
University of Toledo Principal Investigator 
 
 
Printed Name 
 
 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Version date: 6/28/2017 
 
 
 
 
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Study Schema 
 
                                                                                                                            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    SBS II: positive for TH 4 and 5, negative for TH 0, 1, 2, 3, or 6                      
mammogram: negative for BIRADS 1 and 2, positive for BIRADS 0, 3, 4, 5, or 6 
 
List of Abbreviations 
CBE 
 
Clinical Breast Exam 
FSM 
 
First Sense Medical®, LLC 
SBSII                    Sentinel Breast Scanner 
TS 
 
Therma-Scan Reference Laboratory, LLC (analyzes and produces report) 
FS/TS  
First Sense/Therma-Scan 
MMG  
Mammogram 
PPV 
 
Positive Predictive Value 
PI 
 
Principal Investigator  
IRB 
 
Institutional Review Board 
 
Routine and 
necessary 
F/U imaging 
+/- biopsy 
Sponsor 
request US 
Annual  
with 
 
Routine and 
nec F/U 
imaging +/- 
biopsy 
Routine and 
necessary 
F/U imaging 
+/- biopsy  
 
with 
routine 
imaging 
every 6 
to 12 
months 
Annual  
with 
 
with 
routine 
imaging 
every 6 
to 12 
months 

 
Version date: 6/28/2017 
 
 
 
 
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Introduction 
First Sense Medical®, LLC is a medical device company which has developed a breast cancer 
screening device, the Sentinel Breast Scan II [SBSII]. This radiation free device is being developed to 
produce data which will be analyzed by Therma-Scan Reference Laboratory.  Dr. Hoekstra, CEO of 
Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% 
sensitivity and 91% specificity1. The SBSII examination will take approximately 7 minutes.  
This study is designed to evaluate the Sentinel Breast Scan II® as well as the analysis of data by 
Therma-Scan.   SBSII® thermal breast data is an adjunctive aid to standard breast imaging. Currently, 
mammography is one of the standards of care in screening for visible signs of breast cancer. Breast 
thermology is the analysis of the heat signature data from an examined breast.   All study costs will be 
incurred by the sponsor.  Study subjects will incur no cost to participate.  All scientific data revealed in 
this protocol will be used for the specific objectives of the study. The SBSII is a non-significant risk 
device. There is no contact with the subject during the entire procedure. 
Background Information 
1.1 Breast Cancer Screening Today 
Screening is testing of asymptomatic (without symptoms) and symptomatic women. 
Mammograms identify abnormalities and determine their location in the breast. If a biopsy of the area in 
question is positive, treatment includes surgical removal of the cancer followed by radiation and medical 
therapy, if indicated.  The standard protocol in the United States for Breast Cancer screening includes an 
annual clinical breast exam and mammogram for women over 40 years of age2 . Women with a family 
history of Breast Cancer or other indicators may be screened at an earlier age and more frequently. If the 
results are positive, further diagnostic testing may be prescribed and a biopsy may be taken.  If the SBSII 
scan reveals a thermal pattern on analysis that meets established criteria and the mammogram is read as 
normal, FSM intends to contact the site PI. The study participant will then be encouraged to undergo 
additional standard diagnostic imaging tests. These additional tests are performed to assure that the 
patient has no evidence of abnormality utilizing advanced breast imaging techniques in use today.  
However, the additional tests ordered may indicate the need for further investigation prescribed by the 
study doctor.  These imaging tests will be paid for by First Sense Medical. 
 
1.2 Therma-Scan System 
First Sense Medical® has partnered with Therma-Scan Reference laboratory, an established 
pioneer in medical thermology.  Therma-Scan has been in operation for over 40 years and operates a 
diagnostic clinical imaging facility in Birmingham, Michigan. Dr. Philip Hoekstra has developed a complex 
and inclusive protocol for the detection of tissue abnormalities indicative of Breast Cancer. He has 
examined thermology scans on more than 500,000 women using a medical grade digital infrared camera 
                                                          
1Hoekstra P, The autonomic challenge and analytic breast thermology. Thermology International, 2004(14);3:106. 
2American Cancer Society 

 
Version date: 6/28/2017 
 
 
 
 
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that utilizes advanced imaging techniques. Dr. Hoekstra follows an analytic technique derived from the 
Marseille system to provide results of a breast thermogram on a recognized ‘TH’ scale. 
Breast thermology is effective on women of all ages. And the density of breast tissue is not an 
impediment to breast thermal analysis. Utilization of the Marseille system, an internationally standardized 
thermology classification system, defines 5 TH categories based on a range of breast thermal findings; 
these range from TH-1, considered normal, thru TH-5, considered abnormal. Additionally, there are two 
other categories: TH-0, a technically defective test and TH-6, a known biopsy proven cancer. Therma-Scan 
Reference Laboratory will screen for thermal signs indicative of change and report the findings using this 
proven system.   
 
1.3 Sentinel Breast Scan® System [SBSII] 
 
The SBSII will automate the recording of thermal data used in the Therma-Scan manual 
thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature.  The SBSII 
system uses a very sensitive thermography camera that detects and visually displays heat patterns that 
naturally emanate from the breast.  SBSII captures this data digitally for subsequent analysis by Therma-
Scan.  
This study will evaluate the clinical efficacy of the SBSII device in patients completing a screening 
or diagnostic mammogram.  The thermal images captured on examination will be analyzed by Therm-Scan 
and the results will be compared to mammographic analysis. If the Sentinel Breast Scan II findings indicate 
a reading of either TH4 or TH5, FSM may request that the patient receive additional testing, ie breast 
ultrasound or MRI. The additional testing that are not considered routine and necessary based on 
standard breast imaging, will be paid for by the sponsor, as outlined in the study budget. 
 
1.3.1 
Projected Advantages of Sentinel Breast Scan® Test/Therma-Scan System: 
1. Higher sensitivity and positive predictive value (PPV), Sensitivity measures the percentage of 
positive results when cancer is present. PPV is the true positive rate, and is the percentage of 
abnormalities with a positive result.  The false positive rate is the percentage of normals identified 
as abnormal.  Higher positive sensitivity in a screened population is the goal of all screening 
methods. This parameter will be utilized in the analysis of data from this study.   
2. On average, mammographic sensitivity varies between 60-90%. It is lower in women under age 
40 and in those with dense breast tissue.    
 
3. Year-to-year comparisons.  An important factor in analysis is identification of subtle visual change 
that is detected by comparing a previous mammogram to a current one.  SBSII® seeks to identify 
subtle changes over time in breast thermal signals through the use of sophisticated software. 
  
4. Patient Saftey:  Practice guidelines in the United States delay screening younger women with 
mammography based on the accretion rate of radiation exposure. Thermographic analysis of the 
breast is radiation free and innocuous as a screening modality for younger women and is not 
affected by breast density. 

 
Version date: 6/28/2017 
 
 
 
 
5 
 
5. Greater Access.  Because breast thermography can be performed in a non shielded environment, 
the opportunity to use this technology in a more welcoming environment is apparent. 
 
Objectives/Purpose 
The primary objectives of this feasibility study are to evaluate the functionality and performance 
of a novel adjunctive breast cancer screening system (FSM SBSII/Therma-Scan System) and utilize the data 
to provide further calibration for system software.  
Specific Objective 1: To observe and document the performance of the FSM SBSII automated imaging 
system hardware and software in a clinical setting, and analysis of that data by TS. 
Specific Objective 2: To both modify [if indicated] and measure the accuracy of an established manual 
thermographic analytical protocol (performed by TS), as well as define the approximate location of a 
particular finding and classify thermal irregularities in breast tissue. 
Specific Objective 3: To develop and measure the accuracy of the system software to both approximate 
the geographic location of and classification of thermal change in breast tissue.  
 
Thermal imaging captures the intensity and patterns of skin temperature using a high-
performance infrared (8-14µm wavelength) camera. Pre-cancerous and cancerous breast tissue results in 
regional heating of the skin accompanied by complex irregularities in vascular patterns and aberrations in 
the adaptive modulation of skin temperatures3. This information can be imaged by thermal cameras and 
will be analyzed by TS. Although thermography cameras have been approved by the FDA for adjunctive 
use in breast cancer screening, this technology has not been widely accepted for several critical reasons. 
Lack of adequate quality control, adherence to standards for experience and training and inconsistency 
from practitioner-to-practitioner in the application of this technology have resulted in published studies 
with wide ranging sensitivity and specificity (Fitzgerald and Berentson-Shaw 2012). Because of this 
clinicians have been prevented from formulating a reasoned conclusion about the efficacy of breast 
thermography as adjunctive to standard breast imaging or its value as a method of risk assessment.  Peer-
reviewed clinical studies have amassed thousands of subjects and data points over time. However, a 
scarcity of systematic review and meta-analysis has impeded meaningful comparison to standard breast 
imaging technology (Vreugdenburg, Willis et al. 2013). 
The core strengths of thermography are multi-faceted. Thermography is a fast, non-invasive, low 
cost and painless procedure performed without radiation exposure. Published studies support its use for 
early detection of breast tissue abnormalities and in identifying groups that may be at higher risk for 
developing breast cancer.    
As an adjunct to mammography, thermography may be especially useful for screening younger, 
pre-menopausal women and women with dense breast tissue for whom mammography is less effective 
(Bleyer and Welch 2012).   
                                                          
3 Library, T.-S. R. (2011). "Thermology: Analytic Features." A Professional's Guide To Breast Thermology  
Retrieved January 4, 2013, from http://www.thermascan.com/professionals.html. 
 

 
Version date: 6/28/2017 
 
 
 
 
6 
An automated platform for collecting thermal imaging data that provides objective, interpretative 
guidelines and standardized reporting would be an important adjunctive tool to aid in risk assessment and 
clinical decision-making in breast cancer screening. 
Study Design and Selection and Exclusion of Subjects 
1.4 Study Design: Testing a minimum of 2000 women receiving mammograms (comparing the 
SBSII/TS test results to the mammogram and biopsy results when applicable) 
a. SBSII test will be done before all mammograms, diagnostic or screening 
 
b.  Women must wait a minimum of (3) days between mammography and the SBSII. 
 
c. If the SBSII test is positive and mammography is negative, FirstSense may request a 
breast ultrasound or MRI to determine the accuracy of SBSII.  The acquisition order for 
MRI study will be done with prior approval by FSM. 
 
d. Any study subject, regardless of biopsy diagnosis and treatment, will continue to 
complete the SBS II imaging in conjunction with all future routine and necessary 
mammograms, not to exceed less than 6 months between each SBS II imaging, for up to 
5 years from the start date of the subject’s study participation.  For subjects that 
undergo mastectomy after initial study participation, and are no longer completing 
routine and necessary mammograms, the SBS II will be completed with future routine 
and necessary breast MRI imaging, not to exceed less than 6 months between each SBS 
II imaging, for up to 5 years from the start date of the subject’s study participation. 
1.4.1 
Subject Inclusion Criteria: 
1. Female, over the age of 18 years of age. 
2. Asymptomatic women or women who are being screened for breast abnormality. 
3. Women scheduled for a mammogram or women who have had a mammogram and are given 
3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.  
4. Not pregnant or breast feeding. 
5. Signed Informed consent. 
1.4.2 
Subject Exclusion Criteria: 
1. Subject does not meet inclusion criteria, noted above. 
2. Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours. 
3. Use of nitroglycerin within the last 24 hours. 
4. Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study. 
5. Subject must not have had a mammogram, breast ultrasound, or breast exam within the last 
72 hours prior to the SBS II. 
 

 
Version date: 6/28/2017 
 
 
 
 
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1.4.3 
Subject recommendations to follow prior to and day of Testing: 
1. No use of tobacco within two (2) hours of study. 
2. Subject should refrain from the consumption of caffeinated coffee, tea or any other 
caffeinated products for two (2) hours prior to the examination. This includes energy 
drinks/shots.  
3. Subject should have no exposure to natural or artificial light for chest tanning, three (3) days 
or less prior to study. 
4. Subject should have no exposure to vigorous physical stimulation, examination or 
compression of the breasts (self or clinical examination, ultrasound or mammogram) three 
(3) days or less, prior to study. 
5. Subject should have no exposure to sauna, steam-room or hot/cold packs twenty-four (24) 
hours prior to the study. 
6. Subject should have no evidence of new bruising, rash or skin irritation on the subject’s 
breasts or underarms on the day of the study. 
7. Subject will refrain from using deodorants, creams, powders or lotions that contain talcum 
powder which may cause an inflammation in the breast area on the day of the study. 
8. Subjects exposed to outside environmental extremes, such as very cold or warm 
temperatures, should acclimate in a comfortable room temperature for approximately 
fifteen-twenty (15-20) minutes prior to the equilibration process. 
9. The patient should refrain from exercise, bathing, or showering for one hour prior to 
examination.  
These recommendations should be given to the patient prior to testing and then reviewed with 
them at their scheduled appointment. Should a patient not follow one of the recommendations, the 
study staff should note it on the CRF.  
 
Study Procedure: 
 
The study will initially involve approximately 2000 enrolled subjects. This number can be 
expanded with the consent of FSM and the principle investigator. The study will be led by the Principal 
Investigator (PI), Dr. Haitham Elsamaloty. The testing will be performed at the University of Toledo in 
Toledo, OH. The study staff or PI will speak with prospective women that have been referred to the 
University of Toledo by their physician, are patients of the University of Toledo, or are interested in 
becoming participants in this study.  The study staff or PI will determine whether the patient is eligible to 
participate in this study and provide them the necessary documents to enroll. Women who have not been 
referred by their physician may still be considered for the study provided they are first determined to 
meet study eligibility requirements. The study staff will consent eligible participants using the IRB 
approved Informed Consent Form4.  Each consented participant will be asked to fill out a questionnaire 
to provide pertinent medical information required by the protocol. This information will be utilized to 
determine study eligibility. The study coordinator will assign an arbitrary identifier for each participant 
enrolled in the study. The acquired study data and images will only be identified by the arbitrary identifier. 
Only the study staff and the PI will ever have access to both the participant name and the arbitrary 
                                                          
 

 
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identifier.  
 
Test Procedure: 
Eligible participants will be consented using the IRB approved Informed Consent Form. Ineligible 
subjects will not be enrolled in this study. Study candidates will be given a questionnaire to complete.  
Once the questionnaire is completed by the potential participant, the study staff or PI will verify that the 
information is correct and complete and assess the participant’s study eligibility. 
On the day of the study, the study staff will review the entire test procedure including safety 
precautions with the participant. The study staff will then begin the SBSII initialization procedure. The 
study staff will then assist the subject in preparation for the test. Subjects will be asked to disrobe from 
the waist up and sit in the chair facing the tester. Once the subject is positioned properly in front of the 
tester, the study staff will assure that the subject is comfortable and her arms are properly placed on the 
armrests. 
With the subject properly positioned in front of the SBSII scanner, the study staff will inform the 
subject that the test will take approximately 7 minutes and that there will be no physical contact with the 
tester. The participant will be advised to remain still during the scanning process. 
 
Before thermal image acquisition, the SBS II study staff operator will determine the frontal and 
lateral thermal image acquisition angles using the live thermal image of the subject’s breasts provided on 
the SBSII monitor. Once the angles are determined, the study staff operator will start the test. During the 
first step the patient will acclimate for 30 seconds, then cool air will be blown on the breasts for 
approximately 3 minutes. The air is then stopped and the patient will then acclimate for approximately 3 
minutes. Thermal images are acquired starting at the first step and continuously until after the final 
acclimation step is completed. The patient must remain motionless throughout the initial period of 
acclimation, during the cool air sequence, and the final acclimation sequence in order to capture  thermal 
images in series from the start of the test to its completion.   
 
End of the test: 
 
The test will be completed when the SBSII scanner signals that  all images are acquired. The 
patient is now allowed to move.  
Assessment of Safety and Risk 
The potential risks are identified in this study and tests have been done to mitigate the risk.  
Table 2. Risk Assessment 
Medical Risk 
Initial 
Severity 
Initial 
Frequency 
Control Measures 
Final 
Severity 
Final 
Frequency 
Blowing cold air onto 
participants may 
cause discomfort.  
Low  
Remote  
Participants may leave the 
study any time during a test. 
Minor  
Remote  

 
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Mix a patient’s 
results with another 
patient. 
Low 
Remote 
Each participant will be 
assigned a unique study ID. 
This ID will be entered 
electronically through the 
SBS II Tester User interface. 
This ID will be appended to 
the Thermal Data file names. 
Patients will not receive final 
reports.  
Minor 
None 
 
Discontinuation of the Study 
At any time before or during the SBSII test, a subject is able to cancel or discontinue the clinical 
trial without penalty.  
Data Analysis 
1.5 Data analysis for Specific Objective 1:  
The system hardware and software will be observed and log files will be analyzed by FSM to 
confirm proper operation of the system.   
1.6 Data analysis for Specific Objective 2: 
Thermal imaging data will be assessed by TS according to the internationally standardized 
thermology classification ‘TH’ scale, also known as the Marseilles system (Amalric, Brandone et al. 
1978), which defines five categories of risk assessment. 
The 3D, thermal and visible light data will be analyzed by TS to search for signs and criteria that 
indicate potential breast tissue abnormalities and arrive at a TH1-5 classification. Pattern recognition is 
used to identify blood vessels and measure the temperature points within these vessels. TS employs 
mathematical analysis to reduce the effective temperature variance and determine the probability of 
breast cancer. TS also uses mathematical techniques to measure magnitude of the focal areas on the 
breasts relative to the surrounding area. TS analyzes the average of approximately 10,000 data points and 
compares this analysis to the heat in any local hot spot. Sensitivity and specificity will be calculated by TS 
as described and data will be used to compare results with those from mammography and biopsy reports. 
Clinically, a TH4-5 classification may result in a recommendation from the sponsor for further 
assessment. For study purposes, a comparison of the thermal categorization findings using the Marseille 
system to biopsy results will be analyzed. These results will provide a baseline for the semi-automated 
software analysis. Sensitivity and specificity will be calculated as follows:   
 

 
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10 
 
In addition, the data collected will be used to train, test and measure the accuracy of risk 
assessments utilized in manual thermography analysis when a cold air challenge is introduced into the 
clinical examination procedure.  All data collected from study mammograms and biopsies will be divided 
into a phases consisting of all unblinded exams resulting  in the identification of up to 10 biopsy proven 
cancer cases, a testing phase consisting of all double blinded exams resulting in the identification of up to 
45 biopsy proven cancer cases, and a double blinded clinical trial consisting of all exams resulting in the 
identification of up to 45 biopsy proven cancer cases to measure the accuracy of manual thermography 
analysis as stated in Specific Objective 2. 
1.7 Data analysis for Specific Objective 3: 
The accuracy of the imaging system software to define the approximate location and 
identification of aberrant thermal signatures of increased metabolic activity will be compared to results 
found on analysis of mammographic and biopsy results.  
 
IRB Ethics & Informed Consent: 
The protocol, Informed Consent Form, and relevant supporting information must be submitted to the 
IRB for review and must be approved before the study is initiated.  In addition, any subject recruitment materials 
must be approved by the IRB prior to use. This study will be conducted in accordance with the ethical principles 
that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on 
Harmonization - Good Clinical Practice (ICH-GCP) guidance and applicable regulatory requirements. The study 
will be conducted in accordance with the regulations of the United States Food and Drug Administration (FDA) 
as described in 21 CFR Parts 50, 56 and relevant sections of 21 CFR Part 812, and the IRB requirements. 
 
The sponsor must submit any change to the protocol to the IRB for review and approval before 
implementation.  A protocol change intended to eliminate an apparent immediate hazard to subjects may be 
implemented immediately, provided the reviewing IRB is notified within 5 working days of implementation. 
 

 
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It is the responsibility of the study staff or principal investigator to provide each subject with full and 
adequate verbal and written information, before inclusion in the study, using the IRB approved Informed 
Consent Form, including the objective and procedures of the study and the possible risks involved.  Informed 
consent must be obtained prior to performing any study-related procedures, including screening.  A copy of the 
signed Informed Consent Form will be given to the study subject. 
 
Study Oversight & Clinical Trial Monitoring Plan: 
Proper study monitoring ensures adequate protection of the rights of human subjects, the safety 
of subjects involved in a clinical investigation and the quality and integrity of the data submitted as a result 
of the investigation. Therefore, ongoing monitoring of this clinical research investigation will be conducted 
with the intent to: 
1. Verify that patient consent for study participation has been properly obtained and documented 
ensuring compliance with Good Clinical Practice (GCP) standards and FDA regulations for protection 
of human subjects. 
2. Verify that research patients entered into the study meet inclusion and exclusion criteria. 
3. Verify that the study is conducted in compliance with the protocol. 
4. Verify the accuracy and privacy of the data collected. 
5. Verify that all essential documentation required by GCP standards and IDE regulations are present, 
current and appropriately filed. 
 
Routine monitoring will be scheduled at appropriate intervals, with more frequent visits occurring 
at the beginning of the study.  An initiation visit will take place, followed by routine monitoring visits.  
Additional visits can be scheduled at the request of the PI. 
For each subject enrolled, there will be 100% monitoring of informed consent documents, 
inclusion/exclusion criteria, serious adverse events, and unanticipated adverse device effects.  In addition, 
the first ten (10) subjects enrolled will have 100% of the data collection forms and associated source 
documents reviewed to ensure that all data collection has been completed and to ensure compliance with 
the protocol.  FSM will need to receive copies of IC’s or view them on site to verify they are properly signed 
by participant as well as the person who performed the consenting process. 
Consent Forms 
Review of the consent. The patient must sign the IRB approved version of the Informed Consent 
Form prior to initiation of the protocol. 
a. Verify that a signed and dated Informed Consent Form was obtained from every patient screened 
and that the study staff or principal investigator has signed all consents. 
b. Verify the date that the Informed Consent Form was signed is before any study-related activities 
were performed. 
c. Verify that the correct version of the Informed Consent Form was signed initially and that any 
subsequent versions of the Informed Consent Form which were approved during the time the 
patient participated in the study have also been signed. 
 

 
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Inclusion/Exclusion Criteria: 
1. All inclusion/exclusion criteria must be met to determine subject’s eligibility to enter the trial. 
a. Verify that the study staff or principal investigator has signed a statement confirming patient 
eligibility. 
b. Verify that there are no contraindications to the planned procedures. 
 
Protocol Compliance: 
1. Verify that the study is being conducted in compliance with the current IRB approved protocol. 
2. Verify that the correct protocol version is in place. 
 
AE/SAE Reporting: 
1. Serious adverse events must be reported according to protocol requirements. All AE/SAE events will 
be monitored by and reported to Dr. Darius Francescatti, Quality Control Manager, First Sense 
Medical. An AE/SAE should be reported when any undesirable experience associated with the Sentinel 
Breast Scanner occurs, such as death, life-threatening event, hospitalization, disability or permanent 
damage, required intervention to prevent permanent impairment or damage to persons or device, 
electrical shock from the tester. Subjects should notify the study staff of any AE/SAE they believe 
should be reported. The study staff will then take all measures to ensure this is reported properly to 
the PI and First Sense Medical. Reports should be sent to the PI and Dr. Darius Francescatti, Quality 
Control Manager, First Sense Medical.  
 
2. The following steps should be taken when reporting an AE/SAE: 
a. Verify that the serious adverse event was reported within the proper time period. 
b. Verify that a description of the AE/SAE, interventions, and outcome are described in the progress 
note and have been provided to the study staff. 
c. Verify that a copy of the AE/SAE report and IRB notification are filed in the regulatory binder. 
d. Verify that AE/SAE report(s) have been sent to the IRB/FDA, where required, and is filed in the 
regulatory binder. 
e. Verify that the AE/SAE report(s) have been sent to the PI and Dr. Darius Francescatti, First Sense 
Medical. 
 
 
UADE (Unanticipated adverse device effects) Reporting: 
1. Unanticipated adverse device effects (UADE) must be reported according to protocol, IRB and FDA 
requirements. 
a. Verify that an evaluation of the UADE was completed and that risk determination to subjects has 
been made.   
b. Verify that investigations presenting an unreasonable risk were terminated within 5 days of risk 
determination and fewer than 15 days after receiving notice of such effect.   
c. Verify that an evaluation of the UADE, interventions, and outcome are described in the report. 

 
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13 
d. Verify that the UADE report was sent to the IRB (and FDA, where required) within the 10 working 
day time period and that copies of such correspondence are filed in the regulatory binder. 
e. Verify that a copy of the UADE report, IRB notification, IRB and FDA response are filed in the 
regulatory binder. 
 
Follow Up: 
a. FSM may collect follow up information about study subjects if the study subject completes 
additional testing related to breast screening. 
 
Regulatory Binder: 
The regulatory binder will be checked at each visit to ensure that all required regulatory 
documents have been obtained prior to the start of the study and have been kept current during the 
study.  They include: 
1. Protocol and protocol amendments 
2. Sample, approved Informed Consent form 
3. CVs for investigators and sub-investigators, if applicable 
4. Copies of current licenses and or certifications 
5. Sample CRFs 
6. Subject master log/Subject screening log 
i. 
Must show documentation of existence/participation of subjects 
ii. Must be consistent with information within the CRF and in the individual subject record. 
7. Serious Adverse Event log 
8. IRB approval 
9. IRB composition 
10. IRB correspondence 
11. Signature log 
12. Delegation of Authority log 
13. Visitor log 
i. 
Monitor will sign and date the log indicating: 
ii. Date of the visit 
iii. Name of the individual conducting visit 
iv. Coordinator will confirm that visit took place by initialing. 
14. Correspondence related to the study 
 
Source Documents: 
Source documents are essential documents that individually and collectively permit evaluation of 
the conduct of a clinical study and the quality of the data produced.  Examples of source documents are 
hospital records, office charts, lab reports, x-rays, case report forms when date is entered directly, 
magnetic media, and photographic negatives. 
Specific case report forms in this trial will be considered source documents because the data are 
collected one-on-one with the subject and entered directly onto the case report form. 

 
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14 
The files will be named with the inclusion of a blind patient ID. The patient name will not be in the 
filename or in the contained data. Only the study staff will know the relationship between the patient 
name and ID. 
 
 
Data Management 
 
The FSM will collect the following de-identified data during the study: 
 
• 
3-dimensional data providing shape and profile information of the patient’s breast region. 
• 
Thermal (infrared) images providing temperature information of the patient’s breast and 
subclavian regions (near neck). 
• 
Visible light images providing visual color and skin tone information of the subject’s breast region. 
• 
Log files providing information about SBS II. 
• 
Completed patient CRFs (see below appendix)  
 
This de-identified data will be stored on a secured cloud platform and in the SBS II hard drive and 
will only be accessible by Therma-Scan Reference Laboratory, LLC and First Sense Medical, LLC.  
 
The files will be named with the inclusion of a blind patient ID. The patient name will not be in the 
filename or in the contained data. Only the study staff will know the relationship between the patient 
name and ID. 
 
At Therma-Scan Reference Laboratory, LLC, the files will be stored on secured computers. Only 
selected TS employees trained in HIPAA and PHI protection regulations will have access to this data. Those 
employees will not know or have access to the subject’s ID. 
Intended Use of the Data: 
The ID-protected, 3-dimensional, thermal and visible light data that will be collected by the SBS II 
will be analyzed by TS. The data will be analyzed and compared to mammography, breast ancillary tests, 
and / or biopsy findings, or follow up breast imaging. This protocol is used to search for signs and criteria 
that indicate the potential of breast tissue abnormalities associated with the risk of breast cancer. We 
intend to use this data solely for device development purposes.  The log files will be analyzed by FS to 
confirm proper operation of the SBS II scanner.  These results are not intended for submission to the FDA 
for marketing approval. These results are solely intended to be utilized to further develop and refine the 
FS/TS system and device performance.  These results will not be utilized for any clinical decisions related 
to the subjects included in the study.  
 
Confidentiality: 
All the participants of the study will be assigned a unique patient ID number. The de-identified, acquired 
data will be accessed by trained TS analysts for analysis purposes only. FSM and TS will not have access to 
the patient’s name, address or phone number. Records will be maintained using the unique patient ID 
number and will be stored in a HIPPA compliant manner. 
 

 
Version date: 6/28/2017 
 
 
 
 
15 
References:  
1. Hoekstra P, The autonomic challenge and analytic breast thermology. Thermology International, 
2004(14);3:106. 
 
2. Ng EY, & Kee Ee, Advanced integrated technique in breast cancer thermography. Journal of 
Medical Engineering and Technology, 2008. 32(2), 103-115.  
 
3. Arora Nil Ruggerio 0 , Tousimis E, Swistel AJ, Osborne MP, Simmons RM, Effectiveness of a 
noninvasive digital infrared thermal imaging system in the detection of breast cancer. American 
Journal of Surgery, 2008.196(4): p. 523-526.  
 
4. Keyserlingk JR, Ahlgren PO, Yu E, Belliveau N, Infrared imaging of the breast: Initial reappraisal 
using high-resolution digital technology in 100 successive cases of stage I and II breast cancer. The 
Breast Journal, 1998.4(4): p. 245-251.  
 
5. www.thermascan.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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16 
Appendix A 
Patient Recommended 
Preparation Instructions 
Please follow these recommended preparation instructions prior to your 
FirstSense Breast Exam:  
 
• 
You are asked to avoid any natural or artificial tanning of your chest for two-three (2-3) days 
prior to the study date.  
• 
You must not have had any fever within thirty-six (36) hours of the examination.  
• 
You must avoid ultrasound, mammogram, MRI, and clinical physical examination of the breasts 
for at least three (3) days prior to the examination.   
• 
There should be no bruising, rashes, or skin irritation in the breast area on the day of the study.  
• 
You should refrain from hot yoga, sauna, steam-room, or hot/cold packs in contact with the 
breasts for at least twenty-four (24) hours prior to testing.  
• 
You are asked to refrain from exercise, bathing, or showering for one hour prior to examination.   
• 
Please refrain from using deodorants, creams, powders or lotions containing talcum powder 
which may cause an inflammation in the breast area on the day of the study.   
• 
You are asked to refrain from any tobacco use, or the consumption of caffeinated coffee, tea or 
any other caffeinated products for two (2) hours prior to the examination. This includes energy 
drinks/shots.  
For your comfort, we recommend that you wear a pull over or button down shirt.  
 If you have any questions please contact:   
Stephanie Smiddy, RN, BSN, CCRC  
Clinical Research Manager  
University of Toledo-Health Science Campus  
Phone: 419-383-6962  
Stephanie.smiddy@utoledo.edu  
 

 
Version date: 6/28/2017 
 
 
 
 
17 
 
Appendix B 
 
Questionnaire  
Please provide answers to the following questions:  
1) Has it been 12 months or more since your last menstrual period?  
Yes 
 
No 
What was the date of your last menstrual period? __________________________________ 
 
2) Have you taken contraceptives or prescribed hormone replacement therapy (HRT) containing 
estrogen in the past (3) months? 
 
Yes 
 
No 
 
If Yes, Medication Name_______________________________________________________ 
 
 
3) Do you have any type of thyroid disease? 
 
Yes 
 
No 
 
4) Do you have Raynaud’s Syndrome? 
 
              Yes 
 
No 
 
 
5)  If you have any of the following current breast symptoms today, please circle the symptom and 
location of the symptom: 
 
Please circle one location in each column: 
If applicable: 
 
a. Pain 
Right Breast 
Top 
Inner 
Periareolar 
 
Left Breast 
Bottom 
Outer 
Periareolar 

 
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18 
b. Swelling 
Right Breast 
Top 
Inner 
Periareolar 
 
Left Breast 
Bottom 
Outer 
Periareolar 
c. Lump 
Right Breast 
Top 
Inner 
Periareolar 
 
Left Breast 
Bottom 
Outer 
Periareolar 
d. Changes in physical size 
Right Breast 
Top 
Inner 
Periareolar 
 
Left Breast 
Bottom 
Outer 
Periareolar 
e. Skin discoloration, rash, or 
Right Breast 
Top 
Inner 
Periareolar 
 
orange peel texture 
Left Breast 
Bottom 
Outer 
Periareolar 
 
Office Use Only_____________________________________________________________________ 
Patient ID (University of Toledo)