A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) in Individuals With Non-Melanoma Skin Cancer (NMSC) .
Conditions: Non-melanoma Skin Cancer
Sponsor: Sensus Healthcare

 
 
 
 
Title: 
A Retrospective Registry Study to Evaluate the Long-Term 
Efficacy and Safety of Superficial Radiation Therapy (SRT) in 
Individuals with Non-Melanoma Skin Cancer (NMSC)   
 
Protocol Version:  
 
Version 1.0 Aug 22, 2018 
and Date:  
Protocol No: 
  SRTS-SRT-001 
 
 
 Amendment 1 Date:  
  
 Amendment 2 Date: 
 
 Amendment 3 Date: 
 
Sponsor:  
 
 
Sensus Healthcare 
851 Broken Sound Parkway NW #215 
Boca Raton, FL 33487 
Phone: 561.922.5808 
 
Test Sites: 
William I. Roth M.D. 
Dermatology and Dermatological Surgery 
10075 Jog Road, Suite 206 
Boynton Beach, Florida 33437 
Tel (561) 731-4900 
Fax (561) 731-4419  
william@williamrothmd.com 
 
 
 
 

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SITE INVESTIGATOR SIGNATURE PAGE 
 
Protocol Title: 
 A Retrospective Registry Study to Evaluate the Long-Term Efficacy and 
Safety of Superficial Radiation Therapy (SRT) in Individuals with Non-
Melanoma Skin Cancer (NMSC)   
 
Short Title: 
Long-Term Efficacy and Safety of SRT for NMSC 
 
Lead Investigator: 
 
Protocol Version: 
 
And Date:  
Version 1.0; Aug 22, 2018. 
 
I conﬁrm that I have read this protocol, I understand it, and I will conduct the study according to the 
protocol. I will also work consistently with the ethical principles that have their origin in the 
Declaration of Helsinki and will adhere to the Ethical and Regulatory Considerations as stated.  
 
Site Principal Investigator Name: 
_____________________________________________ 
Site Principal Investigator Signature  
 
Date: 
 
 

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TABLE OF CONTENTS 
TABLE OF CONTENTS ..................................................................................................... iii 
ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................................ v 
ABSTRACT ........................................................................................................................ vi 
1. INTRODUCTION AND BACKGROUND INFORMATION ........................................... 1 
1.1 STUDY CONDITION: NON-MELANOMA SKIN CANCERS (NMSC) ..................................... 1  
1.2 BASAL CELL CARCINOMA (BCC) ................................................................................. 1 
1.3 SQUAMMOUS CELL CARCINOMA (SCC) ...................................................................... 1 
1.4 STATISTICS  ............................................................................................................... 2  
1.5 CAUSE OF NON-MELANOMA SKIN CANCER (NMSC) ..................................................... 2 
1.6 CONFIRMATORY DIAGNOSIS OF NMSC  ...................................................................... 3 
1.7 BCC AND SCC VARIANTS ........................................................................................... 4 
1.8 TREATMENT OPTIONS  ............................................................................................... 4 
2 STUDY JUSTIFICATION AND RATIONALE ............................................................ 5 
3 SUPPORTIVE LITERATURE ................................................................................... 6 
4 REFERENCES ......................................................................................................... 7 
5 STUDY DESIGN ....................................................................................................... 9 
5.2 STUDY OBJECTIVES ................................................................................................... 9 
5.1.1 Primary Objective ............................................................................................... 9 
5.1.2 Secondary Objective .......................................................................................... 9 
5.2 INVESTIGATIONAL PLAN .............................................................................................. 9 
5.2.1 Collecting Sites ................................................................................................... 9 
5.2.2 Data Collection Methodology .............................................................................. 9 
5.2.3 Ethical Considerations ...................................................................................... 10 
5.3 STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ........................................... 10 
5.3.1 Duration of Study .............................................................................................. 10 
5.3.2 Total Number of Study Sites and Projected Subjects  ....................................... 11 
5.4 STUDY POPULATION ................................................................................................. 11 
5.4.1 Inclusion Critiera ............................................................................................... 11 
5.4.2 Exclusion Criteria .............................................................................................. 12 
6 STUDY PROCEDURES ......................................................................................... 12 
6.1 RESEARCH DATA SOURCE ........................................................................................ 12 
6.2 DATA COLLECTION ................................................................................................... 12 
6.3 DATA ELEMENTS ...................................................................................................... 12 
7 REGISTRY ADMINISTRATION  ............................................................................. 14 
7.1 COMPLIANCE STATEMENT ......................................................................................... 14 
7.2 DATA COLLECTION AND MANAGEMENT ...................................................................... 15 
7.2.1 Confidentiality and Privacy ............................................................................... 15 
7.2.2 Providing Results to Subjects  .......................................................................... 15 
7.3 REGULATORY AND ETHICAL CONSIDERATIONS ........................................................... 15 
7.3.1 Risk Assessment .............................................................................................. 15 
7.3.2 Potential Benefits of Participation ..................................................................... 16 
7.3.3 Risk-Benefit Assessment .................................................................................. 16 
7.4 RECRUITMENT STRATEGY ......................................................................................... 16 
7.5 INFORMED CONSENT ................................................................................................ 16 

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7.6 PAYMENT TO SUBJECTS  ........................................................................................... 17 
7.7 CONFIDENTIALITY ..................................................................................................... 17 
8 SAFETY MANAGEMENT  ...................................................................................... 17 
9 PUBLICATION  ...................................................................................................... 18 
10 RESULTS ANALYSIS  ........................................................................................... 18 
10.1 PRIMARY ANALYSIS ................................................................................................. 18 
10.1.1 Cure Rate ....................................................................................................... 18 
10.1.2 Recurrences and Complications  ..................................................................... 18 
10.2 SECONDARY ANALYSIS ........................................................................................... 18 
10.2.1 Subject Demographics .................................................................................... 18 
10.2.2 Lesion Variables  ............................................................................................ 18 
10.2.3 Treatment and Follow-Up ................................................................................ 19 
10.2.4 Treatment Dosage and Schedule .................................................................... 20 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition of Term 
AAD 
American Academy of Dermatology 
AJCC 
American Joint Committee on Cancer 
BCC 
Basal Cell Carcinoma 
ºC 
Degrees Celsius 
CAP 
College of American Pathologists 
CM 
Centimeters 
EBT 
Electronic Brachytherapy 
ECT 
Electrochemotherapy 
ED&C 
Electrodesiccation and Curettage 
`HIPAA 
Health Information Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
HPV 
Human Papilloma Virus 
MMS 
Mohs Micrographic Surgery 
NCCN 
National Comprehensive Cancer Network 
NMSC 
Non-Melanoma Skin Cancer 
PDT 
Photodynamic Therapy 
PHI 
Protected Health Information  
RT 
Radiation Therapy 
SCC 
Squamous Cell Carcinoma 
SRT 
Superficial Radiation Therapy 
U.S. 
United States 
U.S. FDA 
United States Food and Drug Administration  
UV 
Ultraviolet 

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ABSTRACT 
Context 
Non-melanoma skin cancer (NMSC) is the most common cancer in the United States 
(U.S.), with prevalence and incidence rapidly rising. Superficial radiation therapy (SRT) has 
been used for the treatment of NMSC since the 1900s, though its use declined since the 
development of Mohs micrographic surgery. With advances in radiation technology, there is 
a resurgence in the use of radiation therapy, more specifically, superficial radiation therapy 
in the treatment of NMSC.  Superficial radiation therapy provides a viable treatment for 
NMSC but current literature on efficacy and long-term cure rates are needed. 
 
Objectives 
• 
The primary objective of this retrospective analysis is to evaluate long-term efficacy and 
safety of SRT when applied with the Sensus Healthcare SRT-100™ in the treatment of 
NMSC. 
• 
The secondary objectives of this study are to evaluate the data for potential differences 
in cure rates with respect to lesion variables (tumor size, location and type) and patient 
demographics; and to evaluate the relationship between outcomes and treatment 
dosage/fractionation. 
 
Study Design 
• 
The study is a retrospective data registry design. 
• 
The data will be used only as applicable to the objectives of this study.  
 
Setting/Participants 
• 
Retrospective data will be collected from medical records of patients treated for NMSC 
with the SRT-100™ prior to January 1, 2015, with follow-up data available. 
• 
There will be multiple participating study sites in the United States who have access to 
the required patient population medical records.  
• 
The number of participants will be determined by the number of qualifying patient files 
identified cross all participating sites.  
• 
Medical record retrospective data will be included for males and females treated with 
SRT-100™ prior to January 1, 2015 

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• 
January 1, 2015 and for whom follow-up data is available. Subjects will have NMSC 
pathological diagnosis of confirmed squamous cell carcinoma (SCC) or basal cell 
carcinoma (BCC) with Histopathological Grade of G1 (well differentiated); G2 
(moderately differentiated) or Gx (not assessed in report), Qualifying subjects had a 
single lesion treated, or more than one lesion treated with a minimum 5 mm gap 
between the edges of the lesion margins.  
 
Data/Specimen Collection Procedures and Frequency  
• 
Study data will be retrospectively collected from already existing documentation in 
patient files at the participating sites.  
• 
Study staff will perform an initial review of the existing patient charts for patients who 
were treated with SRT-100™ for NMSC prior to January1, 2015. The selected charts 
will be further reviewed for satisfaction of inclusion criteria and presence of required 
data elements. The study staff will extract the required information from the patient 
charts and enter it into an Excel database provided by the study Sponsor.    
• 
The data elements of patient demographics, lesion diagnostic variables and 
characteristics, lesion size and margins, treatment duration, treatment dosage and 
schedule, treatment outcomes (particularly cured vs, non-cured) and follow-up outcome 
variables (particularly incidence of lesion recurrence) will be recorded. 
• 
Data collection will be ongoing until no additional qualifying patient charts are identified 
at the respective study sites. 
 
 
 
 

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1 
INTRODUCTION AND BACKGROUND INFORMATION  
 
1.1 
STUDY CONDITION: NON-MELANOMA SKIN CANCERS (NMSC) 
Non-Melanoma Skin Cancers (NMSC) predominantly (98%) include Basal Cell Carcinomas 
(BCC) and Squamous Cell Carcinomas (SCC).  
 
1.2 
BASAL CELL CARCINOMA (BCC) 
Basal cell carcinomas (BCC) are abnormal, uncontrolled growths or lesions that arise in the 
skin’s basal cells that line the deepest layer of the epidermis. BCCs typically appear as 
open sores (possible oozing or crusting) that don’t heal or recur; raised red patches that 
may itch; pink, red, translucent, shiny or pearly bumps with possible darker areas; pink 
growths with raised edges; or scar-like lesions. They can be fragile and bleed easily such 
as with shaving or a minor injury. BCCs tend to develop on sun-exposed body areas, most 
commonly the face, head and neck. Slow-growing cancers, BCCs rarely metastasize to 
body regions beyond the original lesion site but have the potential to do so if left untreated. 
Delayed or ineffective treatment can also lead to disfigurement of the lesion. If not removed 
completely, BCCs can recur in the same location. Prior BCCs increase the likelihood of 
future BCCs.   
 
1.3.    SQUAMOUS CELL CARCINOMA (SCC) 
Squamous cell carcinomas (SCC) are uncontrolled growths of abnormal cells arising from 
the squamous cells in the epidermis producing keratin. SCCs may appear as scaly red 
patches (that may crust or bleed); open sores (possibly oozing or crusting) that don’t heal or 
recur; or wart-like or elevated growths with a central depression. SCCs typically develop on 
sun-exposed body areas such as the face, ears, neck, lips, back of the hands, arms and 
legs. The skin in these areas often contain signs of sun damage such as wrinkles, pigment 
changes, freckles, “age spots,” loss of elasticity and broken blood vessels. SCCs may also 
develop in scars or chronic skin sores elsewhere on the body, including the genitals, and 
occasionally in actinic keratoses. The natural history of SCCs also varies, from slowly 
enlarging to rapidly growing with significant tenderness and pain. They may become 
disfiguring and fatal if left untreated and allowed to grow.  
 
 
 

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1.4.   STATISTICS 
NMSC is the most commonly occurring type of skin cancer, and skin cancers are the most 
common of all types of cancer (about one-third of all cancers). It is estimated that about 3.3 
million people in the United States (U.S.) are diagnosed with NMSC annually, equating 
about 5.4 million BCCs and SCCs.  The diagnosis and treatment of NMSC in the U.S. 
increased by 77% between 1994 and 2014. It is believed that the increasing incidence of 
NMSC is due to better skin cancer detection, increasing sun exposure, and longer 
lifespans. 
 
The incidence of basal cell carcinoma is about 4 times that of squamous cell carcinoma. An 
estimated 4.3 million cases of BCC are diagnosed annually in the U.S. resulting in over 
3,000 deaths. Over 1 million cases of SCC are diagnosed in the U.S. annually, resulting in 
over 15,000 deaths. SCC has a 4% annual incidence of metastasis. 
 
About 90% of NMSC is associated with exposure to ultraviolet (UV) radiation from the sun. 
 
1.5. CAUSE OF NON-MELANOMA SKIN CANCER (NMSC) 
NMSC primarily results from repeated and unprotected skin exposure to ultraviolet (UV) 
rays from sunlight and man-made sources such as tanning beds. UV rays can damage the 
DNA inside skin cells that comprise genes that control cell function.  
 
It is believed that most NMSC are the result of DNA changes from UV ray exposure that 
affect the tumor suppressor genes in cells. Tumor suppressor genes are those that keep 
cell growth in check by slowing down cell division or causing cells to die at the right time. 
The gene most often altered in SCC is TP53, the tumor suppressor gene that normally 
functions to cause cells with damaged DNA to die. When TP53 is altered, these abnormal 
cells may live longer and proceed to become cancerous. 
 
In BCC, the most common mutated gene is PTCH1, a tumor suppressor gene that typically 
functions to keep cell growth in check. Changes to PTCH1 permit cells to grow out of 
control.  
 
These are not the only gene changes that play a role in the development of skin cancer. 
There are likely to be many others as well. 

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Additional risk factors for the development of NMSC include radiation therapy, lighter skin, 
prolonged immunosuppression, human immunodeficiency virus (HIV), human papilloma 
virus (HPV), and certain syndromes or genetic disorders. 
 
Increased risk of multiple NMSC lesions is associated with males, tumor locations in the 
trunk and extremities, superficial histologic subtype, younger age at initial diagnosis, and 
red hair phenotype.  
 
1.6.   CONFIRMATORY DIAGNOSIS OF NMSC 
Dermoscopy is commonly used as an initial aid for early evaluation, identification and 
diagnosis of NMSC. Confirmatory diagnosis is subsequently made through clinical 
(physical) examination followed by histological excision (biopsy – most commonly punch or 
shave biopsy).  
 
(i)  Clinical assessment of the lesion involves evaluation of tumor size (diameter) and 
anatomical location; determination of lesion recurrence; determination of lesion 
connection to underlying structures such as muscle, cartilage or bone; 
classification/grading of the borders (SCCs); and notation of evidence of prior surgery 
or treatment. If an SCC is suspected, lymph nodes are examined for potential 
metastasis.  
 
(ii) Histological examination of NMSC is critical to confirming the clinical assessment, 
confirming the histopathological type as BCC or SCC, and if applicable, the degree of 
differentiation of SCC. Histopathological assessment involves evaluation of tumor 
depth; presence of ulceration (BCCs); morphological subtype; histopathological 
features (SCCs); and perineural or vascular involvement.  
 
 
 

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1.7.  BCC AND SCC VARIANTS 
BCC and SCC variants are listed in the table below. 
BCC Variants 
SCC Variants 
BCC nodular 
SCC in situ/Bowen's disease 
BCC superficial 
SCC invasive 
BCC infiltrative/Morpheaform 
SCC clear-cell 
BCC Basosquamous (metatypical) carcinoma 
SCC Spindle Cell 
BCC spindle cell 
SCC De Novo 
BCC carcinosarcoma 
SCC lymphoepitheliomatous 
BCC pigmented 
SCC Verrucous 
BCC micronodular 
SCC Acantholytic 
BCC trichoblastic 
SCC Desmoplastic 
BCC with follicular differentiation 
SCC HPV induced 
Fibroepithelioma of pinkus 
SCC bowenoid papulosis 
BCC cystic 
 
BCC adenoid cystic 
 
BCC keloidal 
 
 
1.8.  TREATMENT OPTIONS 
The range of available treatment options for NMSC includes surgery, cryotherapy, 
curettage and electrodessication, radiation therapy including superficial radiation therapy, 
photodynamic therapy, various forms of brachytherapy, and chemotherapeutic agents. 
Treatment decisions may be based on tumor type, anatomical location, patient age, tumor 
stage and classification, physician preference, and treatment setting. The choice of 
treatment becomes more complex among the elderly due to frailty, limited life-expectancy, 
and comorbidities. Anatomical location also becomes an important factor as NMSC lesions 
commonly occur on the ears, eyes and nose where treatment may have significant 
cosmetic consequences. 
 
This study will focus on evaluation of outcomes of Superficial X-ray Therapy (SRT), a non-
surgical option for patients with primary non-aggressive BCC and SCC and for patients who 
decline surgery or are poor surgical candidates.  
 
 

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2 
STUDY JUSTIFICATION AND RATIONALE 
Non-melanoma skin cancers are the most common form of cancers with the incidence 
increasing at a rapid rate. Current guidelines (e.g. National Comprehensive Cancer 
Network (NCCN) and American Academy of Dermatology (AAD)) suggest that surgical 
treatments remain the most effective option for the management of most cases of BCC and 
SCC.  
 
Clinical recommendations for radiation therapy (RT) are typically based on consideration of 
RT as a single category without differentiating between the different applications of the 
different available modalities. As different radiotherapy modalities and dosing have been 
shown to result in widely varying outcomes, with recurrence rates ranging from 2.8% to 
30%, such generalized recommendations can be misleading. AAD guidelines group newer 
technologies such as high-dose electronic brachytherapy (EBT) and SRT as new therapies.  
Though the AAD has since clarified these modalities in an addendum position statement it 
continues to refer to SRT as a “new” technology that “differs substantially from traditional 
external beam radiation therapy” and one in need of “research on long term outcomes.” 
  
This retrospective study has been designed to focus on efficacy and safety of superficial 
radiation therapy (SRT) for NMSC and to specifically address this AAD-highlighted 
deficiency and need for long-term evaluation of ’new’ technologies for the treatment of 
NMSC. Evaluation of SRT for NMSC in this study will be via review of retrospective data for 
procedures delivered by the Sensus Healthcare SRT-100™. Sensus Healthcare’s SRT-
100™ has been cleared by the U.S. Food and Drug Administration (U.S. FDA) for the 
treatment of non-melanoma skin cancer and keloids. 
 
The SRT-100™ delivers a precise, calibrated dose of superficial radiation therapy that only 
penetrates skin deep, resulting in a virtually painless treatment can be safely administered 
in the physician’s office.  
 
Low-dose SRT effectively destroys BCC and SCC without any invasive cutting, bleeding or 
stitching. There is no need for anesthesia, no risk of infection or scarring and no need for 
reconstructive plastic surgery. Healing time is quick with minimal to no post-treatment 
downtime or lifestyle restrictions. It is therefore both a viable and highly desirable alternative 
to invasive, painful and higher-risk surgical procedures.    

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While formal long-term outcome evaluations may be lacking, there is much existing data. 
This study will utilize retrospective chart analysis to evaluate the outcomes of SRT-100™ 
therapy on NMSC lesions over a long-term post-treatment period. Long-term cure rate is 
considered the primary outcome, with secondary outcome evaluation focused on the impact 
on cure rate and other treatment outcomes of key variables such as lesion type, location, 
patient characteristics and treatment parameters such as treatment dosing and 
fractionation.  
 
3. SUPPORTIVE LITERATURE 
The following study published in 2012 is similar in design and purpose to the current 
retrospective trial. 
 
Superficial x-ray in the treatment of basal and squamous cell carcinomas: A viable option in 
select patients 
J Am Acad Dermatol December 2012 Volume 67, Issue 6, Pages 1235–1241 
Armand B. Cognetta, MD, Brett M. Howard, BA, Henry P. Heaton, BA, Earl R. Stoddard, 
MD, Hyokyoung Grace Hong, PhD, and W. Harris Green, MD 
 
The abstract from this publication is presented below. 
 
Background: Effective nonsurgical modalities are limited in the treatment of basal cell 
carcinoma (BCC) and squamous cell carcinoma (SCC). 
Objective: We sought to evaluate the efficacy and viability of superficial x-ray therapy in the 
treatment of BCC and SCC in an outpatient setting. 
Methods: A retrospective analysis was performed on 1715 histologically confirmed primary 
cutaneous BCC and SCC treated with superficial x-ray therapy at Dermatology Associates 
of Tallahassee in Florida between 2000 and 2010. 
Results: Of the 1715 tumors reviewed during this period, 712 were histologically proven 
BCC (631 nodular and 81 superficial), 994 were SCC (861 SCC in situ and 133 invasive 
SCC), and 9 displayed distinct features of both BCC and SCC in the same biopsy 
specimen. Kaplan-Meier estimates (with 95% confidence intervals) of cumulative 
recurrence rates of all tumors at 2 and 5 years were 1.9% (1%-2.7%) and 5.0% (3.2%-
6.7%), respectively; of BCC at 2 and 5 years were 2% (0.8%-3.3%) and 4.2% (1.9%-6.4%), 

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respectively; and of all SCC at 2 and 5 years were 1.8% (0.8%-2.8%) and 5.8% (2.9%-
8.7%), respectively. Tumors on male patients and those with a diameter greater than 2 cm 
were associated with a statistically significant increase in recurrence likelihood. 
Limitations: This study represents only patients treated in 1 dermatology office in North 
Florida and may not be representative of the general patient population. 
Conclusions: Superficial x-ray therapy remains a viable nonsurgical option for the treatment 
of primary BCC and SCC in patients where surgical intervention is declined, unadvisable, or 
potentially associated with significant cosmetic or functional limitations.  
 
The present study’s design and intent is to confirm and expand upon these findings. In 
particular, the limitation of the prior study of homogeneity of the population source from 
which the data was drawn will be overcome in the present study, as data from numerous 
sources will be collated and evaluated collectively such that the findings will be 
representative and generalizable to the general patient population. 
 
4.  REFERENCES 
Superficial x-ray in the treatment of basal and squamous cell carcinomas: A viable option in 
select patients 
J Am Acad Dermatol December 2012 Volume 67, Issue 6, Pages 1235–1241 
Armand B. Cognetta, MD, Brett M. Howard, BA, Henry P. Heaton, BA, Earl R. Stoddard, 
MD, Hyokyoung Grace Hong, PhD, and W. Harris Green, MD 
 
Practice and Educational Gaps in Radiation Therapy in Dermatology 
Dermatol Clin July 2016 Volume 34, Issue 3, pages 319-333 Armand B. Cognetta, MD, 
Christopher Wolfe, DO, David Goldberg MD, JD, Hyokyoung Grace Hong, PhD.  
 
New NMSC Guidelines Highlight Options and Need for More Research 
Practical Dermatology, February 2018, pages 56-68 
Jonathon Wolfe, MD 
 
Updates on the Management of Non-Melanoma Skin Cancer (NMSC) 
Healthcare (Basel). 2017 Dec; 5(4): 82. 
Artur Fahradyan, Anna C. Howell, Erik M. Wolfswinkel, Michaela Tsuha, Parthiv Sheth and 
Alex K. Wong 

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Diagnosis and management of nonmelanoma skin cancer 
Prescriber Therapy Review, May 2017; 33-40. 
Califano, J.A.; Lydiatt,W.M.; Nehal, K.S.; O’Sullivan, B.; Schmults, C.; Seethala, 
R.R.;Weber, R.S.; Shah, J.P. 
 
Chapter 15: Cutaneous Squamous Cell Carcinoma of the Head and Neck  
AJCC Cancer Staging Manual, 8th ed.; 
Springer: New York, NY, USA, 2017; pp. 171–181. 
 
Histopathological evaluation of non-melanoma skin cancer 
World Journal of Surgical Oncology 2014, 12:159 
Ali Koyuncuer 
 
Guidelines of care for the management of basal cell carcinoma 
Journal of the American Academy of Dermatology, Volume 78, Issue 3, 540 - 559 
Bichakjian, ChristopherKim, John Y.S. et al. 
 
Guidelines of care for the management of cutaneous squamous cell carcinoma 
Journal of the American Academy of Dermatology, Volume 78, Issue 3, 560 - 578 
Alam, MuradKim, John Y.S. et al. 
 
Additional Sources 
American Cancer Society website: www.cancer.org 
Skin Cancer Foundation website: www.skincancer.org 
American Academy of Dermatology (AAD) NMSC 2018 Guidelines 
 
 
 

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5. STUDY DESIGN 
5.1. STUDY OBJECTIVES 
The purpose of this study is to collate information from existing medical records for patients 
who received treatment with the Sensus Healthcare SRT-100™ for non-melanoma skin 
cancer (NMSC), both SCCs and BCCs, into a central registry database for the purpose of 
retrospective evaluation.  
 
5.1.1. 
Primary Objective 
The primary objective of this study is to evaluate the treatment outcomes of the 
retrospective data for long-term safety and efficacy of application of SRT-100™ for the 
treatment of NMSC (SCC and BCC), including long-term cure rates.  
 
5.1.2. Secondary Objectives 
The secondary objectives of this study are to evaluate the retrospective data for potential 
differences in treatment outcomes, including cure rates, based on lesion variables (such as 
tumor size and location, tumor type), patient characteristics (such as demographics), and 
treatment dosage/fractionation differences. 
 
5.2. INVESTIGATIONAL PLAN 
5.2.1. 
Collecting Sites  
There will be multiple participating sites located in the United States selected based upon 
having access to the required patient population medical records. There is no limit on the 
potential number of participating sites. Each identified and qualifying site that is willing to 
participate in the study will be included.   
 
5.2.2. 
Data Collection Methodology 
Patient data will be retrospectively collected from the medical records and other source 
documentation already existing in patient files at the participating sites.  
 
 
 

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5.2.3. 
Ethical Considerations 
This retrospective chart review qualifies for ‘exempt’ status under human subject 
regulations. Exempt studies are not subject to certain federal research requirements and do 
not require yearly recertification. The determination of ‘exempt status’ for this study is based 
on satisfaction of the following criteria: 1) The study involves the use of existing data, 
documents and records, with ‘existing’ defined as ‘materials that are already in existence at 
the time of the study protocol development’; 2) The protocol specifies a date for data 
collection and review, that is, this study will only collect information that has been recorded 
in charts for patients who were treated for NMSC using the SRT-100™ prior to 01/01/2015; 
and 3) Information recorded will not contain any individual subject identifying information or 
data elements that may potentially link a patient to his or her data. That is, it will not be 
possible to figure out what data belongs to which patient once the data has been recorded 
in the central study database.  
 
This retrospective study will meet Health Insurance Portability and Accountability Act 
(HIPAA) Privacy Requirements by satisfying the criteria for waiver of privacy authorization 
according to the following criteria: 1) There is an adequate plan to protect identifiers from 
improper use and disclosure; 2) There is an adequate plan to destroy any identifiers at the 
earliest opportunity; 3) Protected health information (PHI) will not be re-used or disclosed 
for another purpose; 4) The research could not practicably be conducted without the waiver 
of privacy authorization; and 5) The research could not practicably be conducted without 
the use of PHI. 
 
5.3. 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES 
5.3.1. 
Duration of Study 
Applicable data elements to be reviewed in this study will be collected from patient records 
whose treatment of NMSC with the SRT-100™ occurred prior to 01/01/2015. All applicable 
and available data elements as specified in this study protocol will be recorded for each 
patient from the time of treatment forward to the most recent follow-up data entry date. 
 
Therefore, the study duration of patient participation in this study according to the duration 
of the review of their medical records will vary individually based upon their initial SRT-
100™ treatment date. 
 

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The entire study duration with respect to time from start of patient data identification and 
collation to completion of the final patient data entry will be dependent upon the time 
needed to identify all potential participating study sites and to collate all of the required 
available data from all qualifying patient records at each of those sites. 
 
5.3.2. 
Total Number of Study Sites/Total Number of Subjects Projected 
There will be multiple participating study sites, all located in the United States. Each will be 
selected based upon having access to the required medical records of patients who were 
treated at their site for NMSC with the SRT-100™ prior to January 1, 2015, and for whom 
follow-up data is available. There is no limit on the potential number of participating sites. 
Each identified and qualifying site that is willing and able to participate in the study will be 
included.   
 
Subject data will be retrospectively collected from the existing medical records in the 
identified qualifying patient files at the participating sites as those who were treated with the 
SRT-100™ for one or more NMSCs, who have follow-up data and who subsequently satisfy 
all of the inclusion criteria and none of the exclusion criteria for inclusion of their 
retrospective data in this study. There is no limit on the potential number of study subjects. 
The applicable retrospective data for each identified and qualifying subject at each 
participating study site will be included in the retrospective analysis. 
 
5.4. 
STUDY POPULATION 
The study population comprises patients who were treated at one of the participating study 
sites with the SRT-100™ for one or more NMSCs, who have follow-up data and who satisfy 
each of the study inclusion criteria and none of the exclusion criteria. 
 
5.4.1. Inclusion Criteria  
1. Male or female. 
2. Treatment with SRT-100™. 
3. Treatment date of December 31, 2015 or earlier. 
4. Non-Melanoma Skin Cancer (NMSC) pathological diagnosis of confirmed squamous 
cell carcinoma (SCC) or basal cell carcinoma (BCC). 

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5. Histopathological Grade: G1 (well differentiated); G2 (moderately differentiated) or Gx 
(not assessed). 
6. One lesion is treated, or more than one lesion is treated with a minimum of a 5 mm gap 
between the edges of the lesion margins. 
7. Required retrospective data is existing and sufficient. 
 
5.4.2. Exclusion Criteria  
1. Lesions of etiology other than non-melanoma skin cancer (NMSC). 
 
6. STUDY PROCEDURES 
6.1. 
RESEARCH DATA SOURCE 
The research data source in this study is existing recorded information in patient files at the 
study test sites from patients who received SRT-100™ treatment for NMSC prior to January 
1, 2015 and for whom follow-up data is available. This study is a pure retrospective 
analysis. No additional information will be collected for any subject in this study other than 
the required information that is already existing in their patient file.  
 
6.2. 
DATA COLLECTION 
Study staff at each of the study test sites will perform an initial review of the existing patient 
charts for those who received a diagnosis of NMSC for which they received SRT-100™ 
treatment prior to January 1, 2015 and for which post-procedure follow-up data is available. 
From this initial review, selected charts will be further reviewed for the satisfaction of 
inclusion criteria and presence of required data elements. The study staff will extract the 
required data elements from the patient charts and enter them directly into the Excel 
database provided by the study Sponsor.    
 
6.3. 
DATA ELEMENTS 
The following demographic, lesion, diagnostic, treatment and outcome variables will be 
recorded from the suitably identified existing patient medical records.  
 
A. 
Patient Information and Demographics: 
1. Gender 
2. Age at treatment start 

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3. Ethnicity 
4. Significant comorbidities 
 
B. 
Lesion Diagnostic Variables and Characteristics: 
1. Pathology diagnosis 
2. Diagnosis subtype/variant 
3. Other pathology 
4. Recurrent lesion (yes/no) 
5. Previous treatment if recurrent 
6. Lesion location (no restrictions): scalp, mastoid, forehead, cheek, nose, ear, chin, 
lips, neck, upper arm, lower arm, hand, upper leg, lower leg, foot.   
 
C. Lesion Size and Margins: 
1. Lesion size 
2. Treatment margin 
3. Lead cutout size 
4. Applicator size 
 
D. Treatment Dosage and Schedule: 
1. Treatment dose 
2. Number of treatments  
3. Number of treatments per week 
4. Treatment span(days) 
5. TDF 
6. TX energy KV: 50, 70, 100 
7. Total dose 
8. Break duration (days or N/A)  
 
E. Outcomes: 
1. 
Cured: Yes/No 
2. 
Adverse Events: yes, no 
3. 
Adverse Events description (as applicable) 
4. 
Notes (as applicable) 
 

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F. Follow-Up: 
1. 
Time in months since the most recent follow-up since end of treatment 
2. 
Recurrence: Yes/No 
3. 
Recurrence treatment and outcome (as applicable) 
4. 
Follow-up notes (as applicable) 
 
7. REGISTRY ADMINISTRATION 
Existing patient medical records will only be reviewed by study site staff who already have 
access to the files and who have been trained to the study protocol. Once a qualifying 
patient medical record is identified, the study site staff member will extract only the required 
data elements and enter them directly into an Excel database provided by the study 
Sponsor.  
 
There will be no identifying information entered into the database that could potentially 
connect an individual data record to an individual patient. Unique de-identified codes will be 
used for each patient data set entered into the database. 
 
The collected retrospective data will only be used for the purposes of evaluating the primary 
and secondary objectives of this study.  
 
The parties who will have access to the retrospective data and database will be study site 
investigators and designated study site staff, the study Sponsor and the study 
biostatistician.  
 
Access to the database will not be given to outside parties at any time during the data 
collation and analysis process or in the future for any reason.  
 
7.1. 
COMPLIANCE STATEMENT 
The investigators will perform the study in accordance with this protocol. Identification, 
collection and recording of data will be accurate and will ensure the privacy, health, and 
welfare of patients during and after the data collection process.  
 

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7.2. 
DATA COLLECTION AND MANAGEMENT 
Primary records (source documents) will continue to be maintained in the study site patient 
medical record files as before. The extracted study data elements will be directly entered 
into an Excel database to which only the designated study staff, the study Sponsor and the 
study biostatistician will have access. 
 
7.2.1. Confidentiality and Privacy   
Privacy of subjects and confidentiality of the collected data elements will be secured 
through use of a de-identified coding system that will comprise the first and last name 
initials of the investigator at a test site followed by the order of entry of the subject’s data 
into the database from 001 onwards, as applicable. For example, the third suitable patient 
record to be identified at Dr. John Black’s study site would have a de-identified entry code 
of JB003. 
 
A separate sheet containing the link between the code and the subject’s medical file will be 
maintained in a separate location at each respective test site until such time that all the 
pertinent data has been collated, entered into the database and double-checked for 
accuracy and completeness. At this time, all copies of the sheets containing the link 
between the code and the subject’s medical file at each study site will be destroyed. 
 
7.2.2. 
Providing Results to Subjects 
Results will not be provided to subjects as there is no diagnostic or otherwise medical 
purpose associated with this retrospective analysis that could in any potential way benefit 
the patients whose data was included in the analysis or alert them to potential risks or 
issues in any other regard. 
 
7.3. 
REGULATORY AND ETHICAL CONSIDERATIONS 
7.3.1. Risk Assessment 
The only potential risk to subjects in this study is breach of privacy and confidentiality. The 
application of a de-identified coding system to record patient data has been established to 
minimize this risk.   
 

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7.3.2. Potential Benefits of Participation 
There is no direct benefit to the study subject from participation in this registry trial. Indirect 
benefit to potential future patients is the provision of data and information to physicians who 
treat individuals with NMSC that may enable them to consider non-invasive SRT as a viable 
treatment option. 
 
7.3.3. Risk-Benefit Assessment 
The Risk-Benefit assessment reveals no negatives in conducting this retrospective 
analysis.   
 
7.4. 
RECRUITMENT STRATEGY 
Initially, eligible study sites will be identified and selected as those who have treated NMSC 
patients with SRT-100™ prior to January 1, 2015 and for whom follow-up data is available.  
This study is a pure retrospective analysis. No additional  
 
information will be collected for any subject in this study other than the required information 
that is already existing in their patient file.  
 
At each study site, designated and trained study staff will perform an initial review of the 
existing patient charts for those who received a diagnosis of NMSC for which they received 
SRT-100™ treatment prior to January 1, 2015 and for whom follow-up data is available. 
From this initial review, selected charts will be further reviewed for the satisfaction of 
inclusion criteria and presence of required data elements.  
 
7.5. 
INFORMED CONSENT 
This retrospective study meets the criteria for waiver of consent, assent and HIPAA 
authorization according to the following criteria: 1) There is an adequate plan to protect 
identifiers from improper use and disclosure; 2) There is an adequate plan to destroy any 
identifiers at the earliest opportunity; 3) Protected health information (PHI) will not be re-
used or disclosed for another purpose; 4) The research could not practicably be conducted 
without the waiver of privacy authorization; and 5) The research could not practicably be 
conducted without the use of PHI. 
 

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All of the data is collected retrospectively from information already recorded in existing 
patient medical files. 
 
7.6. 
PAYMENT TO SUBJECTS 
Patients whose data is collected in this retrospective analysis will not receive payment or 
any other form of compensation. 
 
7.7. 
CONFIDENTIALITY 
All data and records generated during this study will be kept confidential in accordance with 
HIPAA regulations on subject privacy. The Investigator and other site personnel will not use 
such data and records for any purpose other than conducting the study. Coded de-
identifiers will be used for all data entries. 
 
8. SAFETY MANAGEMENT 
Safety management, including adverse event evaluation and reporting, is not applicable to 
this registry trial as all evaluations are being performed on prior existing data. 
 
9. PUBLICATION 
It is intended that the outcome of this retrospective registry analysis be written up for 
publication in a peer-reviewed journal. In any potential publication, there will be no 
identifiable information for any individual subject and no individual case studies will be 
profiled. 
 
 
 
 
 
 
 
 
 
 
 

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10. RESULTS ANALYSIS 
10.1. PRIMARY ANALYSIS 
Primary analysis of the retrospective data set will be assessment of cure rates and 
incidence of reoccurrence of lesions. 
 
10.1.1. Cure Rate 
Cure rate will be calculated as the percentage of lesions that attained complete cure 
following treatment completion, reported as the overall success rate. 
 
10.1.2. Recurrences and Complications  
Each identified incidence of lesion recurrence, complication or adverse event recorded at 
any point throughout the treatment and follow-up evaluation phase will be explored 
descriptively. Statistical evaluation of recurrences will be as follows: 
(i) Kaplan-Meier Survival Probability Estimates will be calculated across the duration of 
available follow-up data, reporting survival probability estimates, and lower and upper 
limits of the 95% Confidence Interval by follow-up year.  
(ii) Log-Rank Test will be performed to evaluate for differences in recurrence-free survival 
between lesion types. 
(iii) Multivariate Cox Regression Analysis will be performed to account for the contribution 
of the potential influential factors of gender, age, lesion type, lesion size, total treatment 
dosage and TDF to recurrence-free survival.  
 
10.2. SECONDARY ANALYSIS 
Secondary analysis of the retrospective data set will be both descriptive and statistical, as 
follows. 
 
10.2.1. Subject Demographics 
Descriptive evaluation (mean, standard deviation and range) of the subject demographics 
of age and gender will be performed on a subject rather than lesion basis. 
 
10.2.2. Lesion Variables 
(i) 
Lesion Type and Location: The distribution (number and percentage) of lesion type 
(BCC and SCC) and the distribution of lesion subtype within each lesion type will be 

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calculated. The distribution of the location of lesions on the body will also be 
calculated. The findings will be presented descriptively in table and chart format.  
(ii) Comorbidities: The distribution (number and percentage) of comorbidities for lesions 
overall and by lesion type will be calculated and presented descriptively in table and 
chart format. 
(iii) Lesion Size: Descriptive evaluation (mean, standard deviation and range) of baseline 
lesion size (diameter) in centimeters (cm) will be calculated for lesions overall and by 
lesion type. T-test analysis for two independent samples will be applied to assess for 
any difference in lesion size between lesion types. A two-tailed p value of <0.05 will be 
considered statistically significant and indicative of a clinically meaningful difference. 
The categorical distribution (number and percentage) of lesion size for all lesions and 
by lesion type will also be calculated.  
 
10.2.3. Treatment and Follow-Up 
(i) 
Treatment Period: Descriptive evaluation (mean, standard deviation and range) of the 
number of treatment days will be calculated for lesions overall and by lesion type. T-
test analysis for two independent samples will be applied to assess for any difference 
in the number of treatment days (the treatment administration period) between lesion 
types. A two-tailed p value of <0.05 will be considered statistically significant and 
indicative of a clinically meaningful difference.  
(ii) Follow-Up Evaluation Period: Descriptive evaluation (mean, standard deviation and 
range) of the number of follow-up months will be calculated for lesions overall and by 
lesion type. T-test analysis for two independent samples will be applied to assess for 
any difference in the number of follow-up months (the follow-up evaluation period) 
between lesion types. A two-tailed p value of <0.05 will be considered statistically 
significant and indicative of a clinically meaningful difference. The categorical 
distribution (number and percentage) of the follow-up evaluation period by year for all 
lesions and by lesion type will also be calculated. 
 
 
 
 

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10.2.4. Treatment Dosage and Schedule 
(i) 
Treatment Dosage: Descriptive evaluation (mean, standard deviation and range) of 
the treatment dosage variables of total dosage, Fx Dose, TDF and KV will be 
calculated for lesions overall and by lesion type. T-test analysis for two independent 
samples will be applied to assess for any differences in each of the dosage variables 
between lesion types. A two-tailed p value of <0.05 will be considered statistically 
significant and indicative of a clinically meaningful difference. 
(ii) 
Treatment Frequency: Descriptive evaluation (mean, standard deviation and range) of 
treatment frequency (number of treatment visits and number of treatment visits per 
week) will be calculated for lesions overall and by lesion type. T-test analysis for two 
independent samples will be applied to assess for any difference in treatment 
frequency between lesion types. A two-tailed p value of <0.05 will be considered 
statistically significant and indicative of a clinically meaningful difference. 
 
Furthermore, the categorical distribution (number and percentage) of the number of 
treatment visits and of the frequency of treatment visits per week will be calculated for 
lesions overall and by lesion type.