Pilot Trial Evaluating a Miniature Radiofrequency Tag for Localization of Non-palpable Breast Lesions for Surgery
Phase: NA
Conditions: Breast Neoplasm, Lesion
Sponsor: Jonsson Comprehensive Cancer Center

                LOCALIZER003 STUDY PROTOCOL 
 
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UNIVERSITY OF CALIFORNIA LOS ANGELES 
1245 16th Street, Suite 312 
Santa Monica, CA 90404 
 
 
 
 
PROTOCOL TITLE 
Pilot trial evaluating a miniature radiofrequency tag for localization of non-palpable 
breast lesions for surgery 
 
 
 
 
PROTOCOL NUMBER 
LOCALIZER003 
 
NCT03202472 
 
 
 
 
Original Protocol Date: February 6, 2017 
Revision Date: July 10, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                LOCALIZER003 STUDY PROTOCOL 
 
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Confidentiality Statement 
 
The information contained in this document is privileged and contains confidential information. 
Any other distribution, copying or disclosure is strictly prohibited unless such disclosure is 
required by federal regulations or state law. Persons to whom the information is disclosed must 
be informed that the information is confidential and may not be further disclosed by them. 
 
 
 
PRINCIPAL INVESTIGATOR: 
 
 
Maggie DiNome, MD, FACS 
 
 
 
 
 
 
UCLA Santa Monica Breast Center 
 
 
 
 
 
 
1245 16th Street, Suite 312 
 
 
 
 
 
 
Santa Monica, CA  90404 
 
 
 
 
 
 
 
 
Phone #: 424-259-8791 
 
CO-INVESTIGATORS: 
 
 
 
Deanna Attai, MD, FACS 
 
 
 
 
 
 
UCLA Health Burbank Breast Care 
 
 
 
 
 
 
191 South Buena Vista, Suite #415 
Burbank, CA  91505 
 
 
 
 
 
 
Phone #: 818-333-2555 
 
 
 
 
 
 
 
Cheryce Fischer, MD 
 
 
 
 
 
 
UCLA Barbara Kort Women’s Imaging Center 
 
 
 
 
 
 
1260 15th Street, Suite 111 
 
 
 
 
 
 
Santa Monica, CA  90404 
 
 
 
 
 
 
Phone #: 310-393-5153 
 
 
 
 
 
 
 
Anne Hoyt, MD 
 
 
 
 
 
 
UCLA Barbara Kort Women’s Imaging Center 
 
 
 
 
 
 
1260 15th Street, Suite 111 
 
 
 
 
 
 
 
 
Santa Monica, CA  90404 
 
 
 
 
 
 
Phone #: 310-393-5153 
 
 
 
 
 
 
 
Amy Kusske, MD, FACS 
 
 
 
 
 
 
UCLA Santa Monica Breast Center 
 
 
 
 
 
 
 
1245 16th Street, Suite 312 
 
 
 
 
 
 
Santa Monica, CA  90404 
 
 
 
 
 
 
Phone #: 424-259-8791 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
 
WL 
 
 
 
 
Wire localization 
 
RSL 
 
 
 
 
Radioactive seed localization 
 
RFID 
 
 
 
 
Radio Frequency Identification 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. STUDY SUMMARY 
 
1.1 
Study Population 
 
Patients who require breast surgery of a non-palpable breast lesion and would 
otherwise require wire localization (WL) of the lesion on the morning of surgery. 
 
 
1.2 
Study Duration 
 
The estimated duration of the study is one year. 
 
1.3 
Study Center(s) 
 
UCLA Health System Sites 
 
1.4 
Objectives 
 
This pilot study will evaluate the feasibility of utilizing a new FDA-cleared 
radiofrequency tag for localization of non-palpable breast lesions and provide 
preliminary data for a larger study. 
 
1.5 
Number of Subjects 
 
The projected enrollment is 50 patients 
 
1.6 
Statistical Methodology 
 
For binary outcomes, exact confidence bounds will be reported for all 
proportions. For the three Likert questionnaires, a total score will be computed 
for each and summary statistics will be reported for the total score and for each 
item as well as confidence bounds for the median or mean. 
 
 
2. INTRODUCTION AND BACKGROUND 
 
Wire localization (WL) has been the standard localization technique for guiding 
surgical excision of non-palpable breast lesions for over 20 years (1-3). It is effective in 
localizing the intended target with failure rates between 1-6.7% (4-6) but it carries risks 
inherent in the technique of placing a wire into a patient’s breast. For one, a portion of 
the wire must reside outside of the breast so the surgeon can use the trajectory of the 
wire to guide the surgical resection. In this case, the wire can be inadvertently dislodged 
at any point following the wire placement and before the ultimate wire removal in the 
operating room (7). Also, given its external component, the WL procedure must be 

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performed on the same day of surgery, which can delay surgical start times and impede 
operating room efficiency. 
 
The WL procedure is performed by the breast radiologist in the Imaging Center on 
the morning of surgery. The procedure is performed under local anesthesia in either the 
upright, supine or prone position, depending on the lesion location and the method of 
image guidance for wire insertion.  Patients arrive at the facility on an empty stomach 
given that they are having surgery that same day. It is not uncommon for patients to 
experience lightheadedness and become vasovagal from the localization procedure.  
Despite these inconveniences for patients, WL has remained the primary method for 
localizing non-palpable breast lesions for surgery for both benign and malignant disease.  
 
With screening mammography, the rates at which breast cancers are being 
diagnosed at a non-palpable, early stage has grown considerably, increasing the number 
of breast cancers that require image-guidance for excision. Although WL remains the 
most utilized method for localizing non-palpable breast cancers, the rates of positive 
margins varies widely with this approach ranging from 12-60% (8-10). Given this and the 
technical difficulties associated with WL, alternatives have been sought that may 
improve outcome for patients with breast cancer treated with breast conservation 
surgery.  
 
Radioactive seed localization (RSL) has emerged as an alternate and possibly more 
favorable option for localization and has been a widely studied alternative. Unlike the 
wire, the radioactive seed is implanted entirely within the breast and this can be 
performed at any time within 5 days of surgery. Studies have demonstrated the 
effectiveness of RSL in appropriately targeting the lesion for removal (10,11). In 
addition, RSL appears to equal if not improve the negative margin rate and re-excision 
rate for lumpectomies for breast cancer compared to WL (12-14). Nonetheless, RSL has 
not been easy to adopt given the regulations necessary to manage and track the 
radioactive seeds, the special licensing necessary for handling radioactive material, and 
the coordination necessary between the different departments.  
Other alternatives for lesion localization are under active investigation. A magnetic 
seed called the Magseed is currently being evaluated in a clinical trial at MD Anderson 
(Clinicaltrials.gov). Preliminary concerns include difficulty with the large size of the 
probe compared to incision size for seed detection and the interference from the metal 
surgical instruments which are used during surgery. In addition, presence of the 
magnetic seed is a contraindication for the higher power 3T MRI’s used to evaluate 
breast lesions and may impose significant artifact if used with the 1.5T MRI’s.  For these 
reasons, we are seeking an alternative for lesion localization. 

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Our proposed study is a pilot study to evaluate a recently FDA-approved 
radiofrequency tag for Radio Frequency Identification (RFID) of non-palpable breast 
lesions for surgery. RFID technology is already widely used outside of medicine, most 
commonly in the microchip for pet identification. The radiofrequency tag (or microchip) 
is passive and has no internal energy source unlike the radioactive seed. The LOCalizer 
probe used to read the tag in the operating room emits a signal that then completes a 
circuit with the tag that allows for localization and detection. Similar to the radioactive 
seed and unlike the wire, the RFID tag is inserted completely within the breast allowing 
uncoupling of the localization procedure from the day of surgery. But, unlike the 
radioactive seed, there is no concern for signal decay so the RFID tag can be inserted up 
to 30 days prior to surgery. This allows for more flexible scheduling for tag insertion and 
allows for scheduling of surgeries for first case start times, improving overall operating 
room efficiency. Also, since the RFID tag is not radioactive, it does not require special 
handling and tracking. And, unlike any other localization method currently available, 
RFID with the LOCalizer can read distance in millimeters from the tag, which in theory 
will help guide surgical dissection and possibly reduce rates of positive margins.  
 
Radiofrequency technology has been approved by the FDA for implantation in 
humans for purposes of identification. Further studies have expanded this technology 
for use as a localization method as well. In the medical field, RFID tags have been 
evaluated for their use in guiding positioning of endotracheal tubes for intubation (15) 
and locating surgical sponges in body cavities (16). Proof of concept studies have also 
been performed demonstrating the feasibility of using RFID technology for localizing 
tumors (17). 
 
A prospective clinical study evaluating the safety of RFID technology for localization 
of non-palpable lesions in the breast was performed at Harbor UCLA (18). In this safety 
analysis study, 20 patients underwent both wire placement and radiofrequency tag 
insertion for the localization of non-palpable breast lesions. The radiofrequency tag was 
successfully identified in vivo with the LOCalizer device and the tag and targeted lesions 
were removed successfully in all 20 patients. All cases were performed with IRB 
approval as a Non-Significant Risk device.   
 
We believe that a pilot study evaluating this new technology without concomitant 
placement of a wire is necessary to ensure that surgeons can successfully use RFID 
technology alone to locate non-palpable breast lesions. In addition, a preliminary 
assessment of patient experience and physician experience, evaluation of positive 
margin rates for malignant lesions and determination of volume of tissue removed 
would be helpful for initial evaluation of this technology as a non-inferior alternative to 
WL. Results from this study will inform study design for a larger prospective institutional 
study.   

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3. STRATEGY 
 
We plan to enroll 50 patients with non-palpable breast lesions that require surgical 
removal through the UCLA Health System. The patients may have a diagnosis of breast 
cancer and be undergoing a lumpectomy or they may have a benign lesion requiring 
localization for surgical excisional biopsy. Patients will undergo image-guided placement 
of the radiofrequency tag by our breast radiologists by either mammographic or 
sonographic guidance within 30 days of surgery rather than a wire localization on the 
morning of surgery. The RFID tag will be provided at no cost to the patient. The patients 
will undergo surgery as planned and the surgeons will use a handheld device (LOCalizer) 
to localize the tag during surgery.  Retrieval of the marker will be confirmed by 
specimen radiography performed per standard protocol at the time of surgery. Three 
breast surgeons will be participating and enrolling through 2 UCLA sites. 
 
4. AIMS 
4.1 
Primary Study Endpoints 
a) 
Percentage of patients with successful placement of the RF tag under 
radiographic guidance confirmed by mammography 
b) 
Percentage of patients with successful retrieval of the RF tag confirmed 
by specimen radiography 
4.2 
Secondary Study Endpoints 
 
 
a) 
Patient experience with image-guided placement of tag 
b) 
Radiologist’s experience placing radiofrequency tag compared to WL 
c)  
Surgeon’s experience using radiofrequency tag to guide resection 
compared to WL 
 
 
 
d) 
Percentage of patients with positive margins on initial 
 
 
 
 
 
lumpectomy using RFID technology 
 
 
 
 
 
 
 
 
e) 
Percentage of patients with cancer requiring re-excision   
 
f) 
Volume of tissue removed with specimen with tag (not including shave 
margins, if taken) 
 
g) 
Days prior to surgery of insertion of marker 
 
 
 
h) 
Percentage of patients with documented migration of marker  
 

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5. SUBJECT SELECTION 
 
Patients over the age of 18 who require breast surgery and localization of non-palpable 
breast lesions for surgery will be enrolled. The vast majority will be women given that 
screening mammograms are performed primarily in women and women are diagnosed with 
breast cancer at rates significantly higher than men.  
 
5.1 
Inclusion Criteria 
 
a) 
Able to give written informed consent to participate in the study 
 
b) 
Patients over the age of 18  
 
c) 
Patients with breast lesions that are non-palpable that require surgical 
removal 
 
 
 
d)  
Lesions and/or clip targetable with image guidance 
 
5.2 
Exclusion Criteria 
 
a) 
Multicentric breast cancer 
b) 
Stage IV breast cancer 
 
c)  
Pregnant or lactating females 
 
 
5.3 
SUBJECT RECRUITMENT 
 
Patients will be identified by the treating surgeon during their surgical 
consultation visits. The study will be discussed with them at the time of surgical 
planning in a private room. When potential patients are identified, the treating 
surgeon will explain the study purpose, obtain informed consent, and provide 
the patient with a signed copy.  The patient’s surgery and localization procedure 
will then be scheduled.  

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6. STUDY PROCEDURE 
 
a) Questionnaires: Each subject will complete a patient questionnaire 
(attachment 12.1) following placement of the radiofrequency tag. The 
questionnaires will be completed in a private room immediately following 
the procedure and no later than 24 hours. The questionnaires will be 
labeled with the unique patient identifying number so that clinical outcome 
can be associated with patient reported outcome for data analysis.  The 
radiologist will also complete a questionnaire (attachment 12.2) following 
placement of the marker, and the surgeon will complete a questionnaire 
(attachment 12.3) following the breast surgery. 
 
 
       7.  DATA MANAGEMENT AND EVALUATION 
 
7.1 
Sample Size Determination 
 
Sample size for this pilot study was selected at 50 patients. Since this is not a 
comparative study, the sample size is based on the width of the confidence 
interval, not power. Our primary outcomes are successful placement and 
successful retrieval of the RFID tag. We anticipate 100% success for both 
outcomes. Assuming this is true, a sample size of n=50 allows establishment of 
the lower 95% confidence bound at 94.2%. 
 
The sample size is also based on pragmatics of recruitment and patient flow and 
budgetary constraints. This is a pilot study to determine feasibility of patient 
recruitment for a larger study, implementation of a new FDA-cleared device, 
and modification of the logistics of the study protocol.  
 
 
7.2 
Statistical Methods 
 
≤8 wks 
<  24 hrs 
<30 days 
< 24 hrs 
Enrollment 
Random unique number assigned 
 
Radiofrequency tag placed 
under radiologic guidance  
Patient completes patient 
questionnaire regarding 
marker placement. 
Radiologist completes 
physician questionnaire 
Breast surgery performed 
and RF tag removed 
Surgeon completes 
physician questionnaire  
 
Post-operative visit and end 
of Study 
 
< 2 wks 

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For binary outcomes, exact confidence bounds will be reported for all 
proportions. For the three Likert questionnaires, a total score will be computed 
for each and summary statistics (mean, median, range, proportion who are 
1,2,3,4,5) will be reported for the total score and for each item as well as 
confidence bounds for the median or mean. 
 
7.3 
Safety Analysis of Individual Adverse Experience Reporting 
 
The procedure involved in placing the radiofrequency marker for the research 
study will be included in the safety analysis for adverse event reporting by the 
participant. All adverse events due to these procedures will be recorded and 
reported to the IRB. 
 
Image-guided localization is standard for localizing breast lesions that are not 
palpable and that require surgical removal. The most common localizing device 
is a hooked wire. We are studying a radiofrequency marker as an alternative. 
The patient and/or her insurance will be billed for the standard of care 
procedure of insertion of the localizing device, the localization mammogram, 
the specimen mammogram and the surgery but there will be no cost to the 
patient or her insurance for the RFID tag itself.  
 
Some risks associated with the localization procedure (regardless of the device 
placed) include pain, bruising, bleeding, swelling, infection, lightheadedness and 
dizziness. Less common risks include implant rupture, pneumothorax 
(punctured/collapsed lung) or movement (migration) of the marker after 
placement and before surgery.  The placement of marker may not be successful 
due to inadequate visualization of the abnormality or difficult location of the 
abnormality (too close to the skin surface or too deep in the breast) which 
precludes safe and accurate placement of the marker. In this case, if placement 
of the standard wire is also considered technically impossible then the breast 
imager and surgeon will discuss alternatives for lesion localization, such as 
intraoperative ultrasound localization, placement of skin marker, etc. such as is 
standard protocol when wire placement is unsuccessful.  
 
Failure in this study is defined as inability to localize the lesion with the RFID tag 
but successful localization with the wire. If both approaches are unsuccessful 
then this would reflect an ability to localize the lesion in general, which is a risk 
of image-guided localizations but not a failure of the tag itself. In the case of 
defined failure, the patient will require a second procedure for wire placement 
prior to surgery. Failure would also be defined as inability to retrieve the tag 
and/or the lesion. In this case, the patient would require a second localization 
procedure and surgery.  
 
The risks from participation in this study are minimal. Participation is voluntary 
and participants can withdraw any time after consent but prior to placement of 
the research device without fear of any change in medical treatment.  
 

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An interval analysis will be performed after enrollment of the first 20 patients to 
ensure that the radiologists are able to successfully place the device for 
appropriate lesion localization, surgeons are able to successfully retrieve the 
device, and patients do not experience significant adverse side effects from 
placement of the tag. 
 
The assessment of safety will be based primarily on the frequency of AE’s. The 
research device will most likely be placed within 7 days of surgery but can be 
placed on the morning of surgery out to 30 days prior to surgery. The patient 
will be contacted by study personnel on the day following device insertion 
(unless within 24 hours of surgery) to inquire about adverse events and an AE 
report form will be completed (attachment 12.4). A follow-up visit within 2 
weeks of surgery will also occur and will be the final study visit.  
 
This study will involve two sites, and study personnel will be notified 
immediately regarding any documented AE’s or concerns that impact patient 
safety or continuation of the study.  
 
Given the low risk of this study, there is no anticipated toxicity.  
 
7.4 
Data Collection 
 
All subjects will be assigned a unique identifying number upon signing their 
consent. All data will be identified using this number. No data will be collected 
or stored attached to any identifying information.  Personal/medical history 
data will be kept unidentified according to HIPAA. Personal information and the 
codes associated with the personal information will be maintained in a 
password protected file by the PI, on her computer that is password protected 
and located in a secure office with limited access. The random unique number 
will be used to identify subjects in all electronic spreadsheet collating results.  
 
7.5 
Privacy and Confidentiality 
 
No information that identifies a subject will be released without separate 
consent except as specifically required by law. Information about study subjects 
will be kept confidential and managed according to the requirements of the 
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and in 
accordance with all institutional review board requirements, and all applicable 
policies of the institution. Participants will be assigned a unique study 
identification number which will be the only marker attached to their data 
collection forms. Participants will complete questionnaires in the privacy of a 
closed room. Only the PI will have access to the key linking names and contact 
information with the primary and complete set of data collected, by study 
identification number, and this key will be kept in a password protected 
computer file. All paper records for individual participants will be coded as 
noted above, handled with privacy and confidentiality in mind, and kept in a 
locked file cabinet in the PI’s office. All participant identifiers are removed from 

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Excel tracking spreadsheets.  Medical record review will be limited to the 
patients of the investigators listed on this study. 
 
7.6 
Consent Process 
 
When potential subjects are identified, the treating surgeon will discuss 
the study with the patient and obtain informed consent. Informed 
consent discussion will be performed in a private room/office. A copy of 
the signed consent will be given to the patient. They will be welcome to 
review the forms at home and have an opportunity to discuss their 
participation in the research with whomever they wish. The consenting 
physician will question the prospective subject during the consent 
process to make certain the subject understands the research study as 
well as the risks and benefits of the study. They will also be available for 
questions.  
 
8. STUDY FINANCES 
 
8.1  
Funding Source 
 
All product for the RFID localization procedure will be provided by Faxitron 
Biopics, LLC but this is not an industry-sponsored study.  
 
8.2 
Subject Compensation 
 
There will be no monetary compensation for participation.  
 
8.3 
Commercial Ramifications 
 
There are no commercial ramifications. 
 
9. ADVERSE EXPERIENCE REPORTING 
 
9.1 
Investigator Responsibility  
 
The Code of Federal Regulations, 21 CFR .150(a)(1) states that: An investigator 
shall submit to the sponsor and to the reviewing IRB (Institutional Review 
Board) a report of any unanticipated adverse effect occurring during an 
investigation as soon as possible, but in no event later than 10 working days 
after the investigator first learns of the effect. 
 
 
9.2 
Sponsor Responsibility  
 
The Code of Federal Regulations, 21 CFR 812.150(b)(1) states that: A sponsor 
who conducts an evaluation of an unanticipated adverse effect under 
§812.46(b) shall report the results to all reviewing IRBs and participating 
investigators within 10 working days after the sponsor first receives notice of 
the effect. This study has no sponsor outside of UCLA. 

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For reported deaths, the investigator should supply the IRB with any additional 
requested information (e.g. autopsy reports and terminal medical reports). 
 
9.3 
Principal Investigator Obligations 
 
Maggie DiNome, M.D., F.A.C.S., is the Principal Investigator. All co-investigators 
participating in this research study shall be qualified by education, training and 
experience to assume responsibility for the proper conduct of the study, shall 
meet all the qualifications specified by the applicable regulatory requirement(s) 
and shall provide evidence of such qualifications through up-to-date curriculum 
vitae. Prior to the initiation of the study, the investigator and any co-
investigators will supply UCLA with their curriculum vitae, including a list of 
publications and any other relevant documentation requested by the sponsor, 
the IRB (Institutional Review Board) and/or any other prevailing regulatory 
bodies. 
 
a)  Data 
 
The Principal Investigator is responsible for the accuracy of the information 
collected and entered into the database. All data must be available for review. 
The PI will also allow representatives of the IRB to review the information 
reported in the database and reconcile the data with source documents. 
 
b)  Confidentiality of Subjects 
 
The PI must assure that the subjects’ anonymity will be maintained. All 
documents should identify subjects by identification code only. The PI will 
maintain a separate log of the subjects’ codes, names and center identification 
code and keep it in a locked cabinet. 
 
10. PUBLICATION PLAN 
 
The publication plan will be in accordance with UCLA’s publication policy 
 
 
11. LITERATURE CITED 
 
1. 
Leeming R, Madden M, Levy L. An improved technique for needle localized 
biopsies of the breast. Surg Gynecol Obstet 1993;177:84-6. 
2. 
Greenlee JA, Gubler KD, Goepfert CJ, Ragland JJ. Surgical margins after needle-
localization breast biopsy. Am J Surg 1995;170(6):643-5.  
3. 
Jones MK, Vetto JT, Pommier RF, et al. An improved method of needle localized 
biopsy of nonpalpable lesions of the breast. J Am Coll Surg 1994;178:548-52. 
4. 
Shetty MK. Presurgical localization of breast abnormalities: an overview and 
analysis of 202 cases. Indian J Surg Oncol 2010;1(4):278-83. 
5. 
Jackman RJ, Marzoni FJ. Needle localized breast biopsy. Why do we fail? 
Radiology;1997;204(3):677-84. 

                LOCALIZER003 STUDY PROTOCOL 
 
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6. 
Abrahamson PE, Dunlap LA, Amarnoo MA, Schell MJ, Braeuning MP, Pisano ED. 
Factors predicting successful needle-localized breast biopsy. Acad Radiol 
2003;10(6):601-6. 
 
7. 
Davis PS, Wechsler RJ, Feig SA, et al. Migration of breast biopsy localization wire. 
AJR Am J Roentgenol 1988;150:787-8. 
8. 
Langhans L, Jensen MB, Talman MM, Vejborg I, Kroman N, Tvedskov TJ. 
Reoperative rates in ductal carcinoma in situ vs invasive cancer after wire-
guided breast-conserving surgery. JAMA Surg 2017;152(4):378-84. 
9. 
Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN, Ulloa-Gomez JL, Romero-
Trejo C, Sepulveda-Mendez J. Radioguided occult lesion localization (ROLL) 
versus wire-guided lumpectomy for nonpalpable breast lesions: a randomized 
prospective evaluation. J Surg Oncol 2008;97(2):108-11. 
10. 
Gray RJ, Salud C, Nguyen K, et al. Randomized prospective evaluation of a novel 
technique for biopsy or lumpectomy of nonpalpable breast lesions: radioactive 
seed versus wire localization. Ann Surg Oncol 2001;8(9):711-15. 
11. 
McGhan LJ, McKeever SC, Pockaj BA, et al. Radioactive seed localization for 
nonpalpable breast lesions: review of 1,000 consecutive procedures at a single 
institution. Ann Surg Oncol 2011;18:3096-101. 
12. 
Gray RJ, Pockaj BA, Karstaedt PJ, Roarke MC. Radioactive seed localization of 
nonpalpable breast lesions is better than wire localization. Am J Surg 
2004;188(4):377-80. 
13. 
Dryden MJ, Dogan BE, Fox P, Wang C, Black DM, Hunt K, Yang WT, Imaging 
factors that influence surgical margins after preoperative 125I radioactive seed 
localization of breast lesions: comparison with wire localization. AJR 
2016;206(5):1112-8. 
14. 
Hughes JH, Mason MC, Gray RJ, et al. A multi-site validation trial of radioactive 
seed localization as an alternative to wire localization. Breast J 2008;14(2):153-
7. 
15. 
Reicher J, Reicher D, Reicher M. Use of radio frequency identification (RFID) tags 
in bedside monitoring of endotracheal tube position. J Clin Monit Comput 
2007;21:155-8. 
16. 
Rupp CC, Kagarise MJ, Nelson SM, et al. Effectiveness of a radiofrequency 
detection system as an adjunct to manual counting protocols for tracking 
surgical sponges: a prospective trial of 2,285 patients. J Am Coll Surg 
2012;215:524-33. 
17. 
Reicher J, Reicher M, Thomas M, Petcavich R. Radiofrequency identification tags 
for preoperative tumor localization: proof of concept. AJR Women’s Imaging 
2008;191:1359-65. 
18. 
Dauphine C, Reicher J, Reicher M, Gondusky C, Khalkhali I, Kim, M. A prospective 
clinical study to evaluate the safety and performance of wireless localization of 
nonpalpable breast lesions using radiofrequency identification technology. AJH 
Women’s Imaging 2015;204:W720-3. 
 
12. ATTACHMENTS 
 
12.1 
Patient Questionnaire 
12.2 
Radiologist Questionnaire 
12.3 
Surgeon Questionnaire 

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ATTACHMENT 12.1 
 
Patient Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PATIENT QUESTIONNAIRE 
 
Please do your best to answer the following questions about the localization procedure. Please 
circle one number per line to indicate your response as it applies. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Strongly 
disagree 
Disagree 
Neutral 
Agree 
Strongly 
agree 
 
1. 
The procedure was not very painful 
 .................................................................. 
. 
1 
2 
3 
4 
5 
 
 
2. 
The procedure was easier than the biopsy 
 ..................................................................  
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
3 
I did not feel lightheaded or dizzy during 
the procedure 
 ..................................................................  
 
1 
2 
3 
4 
5 
 
4. 
The procedure was easier than I 
expected
 ..................................................................  
 
1 
2 
3 
4 
5 
 
5. 
The procedure went smoothly 
 ..................................................................  
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 
       
 

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ATTACHMENT 12.2 
Radiologist Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RADIOLOGIST QUESTIONNAIRE 
 
Please do your best to answer the following questions about the localization procedure. Please 
circle one number per line to indicate your response as it applies, and please use the wire 
localization procedure as the comparison 
 
 
 
 
 
Strongly 
disagree 
Disagree 
Neutral 
Agree 
Strongly 
agree 
 
1. 
The procedure took less time than a wire 
localization
 .................................................................... 
. 
1 
2 
3 
4 
5 
 
 
2. 
The  needle was easy to handle 
 .................................................................... 
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
3 
The radiofrequency tag was easy to 
deploy 
 .................................................................... 
 
1 
2 
3 
4 
5 
 
4. 
The targeted lesion was successfully 
localized with the tag 
 .................................................................... 
 
1 
2 
3 
4 
5 
 
 
5. 
The marker seed was easy to visualize on 
post-procedural imaging 
…………………………………………. 
 
1 
2 
3 
4 
5 
 
6. 
The ID# was easy to read after tag 
placement 
…………………………………………. 
 
1 
2 
3 
4 
5 
 
 
 
 
Method of Localization (circle):                Ultrasound               Mammogram          
 
RFID #:    _________________ 

                LOCALIZER003 STUDY PROTOCOL 
 
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ATTACHMENT 12.3 
 
Surgeon Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                LOCALIZER003 STUDY PROTOCOL 
 
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SURGEON QUESTIONNAIRE 
 
Please do your best to answer the following questions about the surgical procedure. Please circle 
one number per line to indicate your response as it applies, and please use the wire localization 
procedure as the comparison 
 
 
 
 
 
Strongly 
disagree 
Disagree 
Neutral 
Agree 
Strongly 
agree 
 
1. 
The procedure was quicker than wire 
localized surgery 
 ..................................................................  
 
1 
2 
3 
4 
5 
 
 
2. 
The RF tag was easy to detect with the  
LOCalizer probe during surgery 
 ..................................................................  
 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
3 
Having the distance gauge was helpful in 
guiding the surgical resection 
 ..................................................................  
 
1 
2 
3 
4 
5 
 
4. 
The RF tag was as easy and reliable as 
the wire in directing the surgical 
excision
 ..................................................................  
 
1 
2 
3 
4 
5 
 
5. 
The RF tag and the clip/lesion was 
successfully removed with surgery 
 ..................................................................  
 
1 
2 
3 
4 
5 
 
 
 
Closest depth measurement of tag from the overlying skin:   _______________________ 
 
Radial distance of tag from the incision:  ______________________ 
 
 

                LOCALIZER003 STUDY PROTOCOL 
 
Page 21 of 22 
 
 
 
 
 
ATTACHMENT 12.4 
 
Adverse Event Reporting Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                LOCALIZER003 STUDY PROTOCOL 
 
Page 22 of 22 
 
Pilot trial evaluating a miniature radiofrequency tag for localization of non-palpable breast 
lesions for surgery:  
Adverse Event Report Form 
 
Subject ID: _________________________________    
        Patient Initials: ________________ 
Date of RFID insertion: _______/_______/_______ 
Date of assessment: _______/_______/_______ 
 
Since the beginning of the trial, has the patient experienced any of the following? 
CTCAE Adverse Events 
Grade 
Attribution Code 
Hematoma 
1          2          3          4          5 
 
Device related infection 
1          2          3          4          5 
 
Vasovagal reaction 
1          2          3          4          5 
 
 
Other Adverse Events 
Grade 
Attribution Code 
 
1          2          3          4          5 
 
 
1          2          3          4          5 
 
 
1          2          3          4          5 
 
 
Attribution codes: 
1. Unrelated (AE not related to protocol treatment) 
2. Unlikely (AE doubtfully related to protocol treatment) 
3. Possible (AE may be related to protocol treatment) 
4. Probable (AE likely related to protocol treatment) 
5. Definite (AE clearly related to protocol treatment) 
Comments: 
______________________________________________________________________________ 
______________________________________________________________________________ 
______________________________________________________________________________ 
 
Person completing form: _____________________________