Prospective Registry of Intraoperative Radiation Therapy Using Low Energy X-ray for Breast Cancer at Medical Center, Navicent Health
Conditions: Breast Cancer Female, Early-stage Breast Cancer
Sponsor: Wake Forest University Health Sciences

Official Title: IRB00092014: IORT-Breast at Medical 
Center Navicent Health 
NCT#: NCT04595435 
IRB-Approved Date: 06/29/2023 

Atrium Health Navicent / IORT
Page 1 of 10
Paul Dale, MD
ATRIUM HEALTH NAVICENT
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
AND AUTHORIZATION TO DISCLOSE HEALTH INFORMATION
For
SUBJECTS 
Sponsor / Study Title:
Atrium Health Navicent / Prospective Registry of Intraoperative 
Radiation Therapy Using Low Energy X-ray for Breast Cancer 
at Medical Center, Navicent Health
Protocol Number:
 IORT
Principal 
Investigator:
(Study Doctor)
Paul Dale, MD
Telephone:
Address:
Version Date February 1, 2019
You are being asked to participate in a research study because you are planning to have low 
energy x-ray intraoperative radiation therapy using Xoft for Breast Cancer (IORT-Breast) at The 
Medical Center, Navicent Health, or you have had this procedure within the last 6 months. Your 
participation in this trial is voluntary, you must choose to participate or not participate. Your 
choice will not affect the care that you will receive. Please take as much time as you require to 
read this Informed Consent and ask questions about participating in this research.
Background on treatment
Intraoperative radiation therapy using low energy x-rays using Xoft (IORT-Breast) is an FDA 
approved treatment, after lumpectomy, for early stage low, risk breast cancer. Breast cancer is 
considered early stage, low risk when there is a single small lump, usually 2cm or less in greatest 
diameter, that has not spread beyond that lump, and the tumor has been shown to be slow 
growing (Low or medium cellular grade). Additionally, these tumors are sensitive to estrogen. 
(ER positive). 
Intraoperative radiation therapy allows for 1 single radiation treatment after lumpectomy but 
during the surgical visit.  This is an alternative to whole breast radiation or mastectomy.  The 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 2 of 10
Paul Dale, MD
risks and benefits of these treatment alternatives have or will be discussed by your physician. 
While Intraoperative Radiation Therapy (IORT-Breast) has been used for many years, it has only 
recently been introduced at the Medical Center, Navicent Health. The researchers would like to 
follow as many women as possible who receive this treatment during the first FIVE years that 
this treatment is offered and to assess your satisfaction and success for TEN years after receiving 
treatment.
Purpose and Duration
The purpose of this research is to determine the treatment outcomes of women with low risk 
breast cancer who receive intraoperative radiation therapy for the 10 years following treatment. 
The researchers hope to be able to follow all women who receive this treatment from October 
2018 to December 2023. It is estimated that this will involve up to 300 women.
Each participant would be followed for up to 10 years after IORT-Breast. The researchers are 
also interested in how your life has been affected by the cancer and its treatment, your “Quality 
of Life”. For this you will receive a short questionnaire at each visit. The QOL questionnaire 
looks at how you are physically and emotionally, and how able you are to carry out your day to 
day living. If any questions make you feel uncomfortable, you may skip those questions and not 
give an answer. This information will help doctors better understand how patients feel and what 
effects treatments and medicines are having.
The researchers are also interested in determining how participants feel that their surgery is 
having on their appearance. There is a brief questionnaire that allows participants and their 
doctors to rate their appearance and satisfaction at each visit.
The trial will be open to accrual from January 2019 until December 2023. Follow up visits 
should be completed by early 2028 and the trial should be completed by December 2033.
Research Activities: Procedures and Information Requested
This research study is an observational registry. There is NO experimental treatments. 
Participants will be treated according to standard of care practices by their doctors.
There are two groups or cohorts, Cohort A includes those who agree to participate in the study 
prior to having surgery and IORT-Breast. This group includes all eligible for IORT-Breast. 
Consent and authorization will be obtained prior to surgery. Those who do not have IORT-Breast 
will have the reasons that IORT-Breast was not received noted and will then have no further 
follow-up. Those who have IORT-Breast will be followed until they have a 10 year post IORT-
Breast follow up.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 3 of 10
Paul Dale, MD
Figure 1: Cohort A Preoperative Prospective
Cohort B are those people who have had IORT-Breast within the preceding 6M. Once consent 
and authorization are obtained they will be followed for 10 years post IORT.
Figure 2: Cohort B Postoperative Prospective
All participants will receive standard of care treatments.
Research Information will be taken from your doctor’s notes following your visits. The 
following information will be recorded.
Height (initial visit)
Weight
Body Mass Index
Eligible for IORT and study
Consent & 
Authorization 
Obtained
Lumpectomy with
Sentinel Lymph Node
IORT Not Received
Record Reasons Why.
No Further Follow-up! 
Iort Received
Follow-up:
Q6M for 2Y
Q12M for 3Y
Q12M for 5Y 
[Total of 10Y]
IORT within last 6 months
Consent & Authorization Obtained
Follow-up:
Q6M for 2Y
Q12M for 3Y
Q12m for 5Y
[Total of 10Y]
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 4 of 10
Paul Dale, MD
History and physical exam findings

Vital Signs

Breast evaluation

Medical Record Review

Imaging Review

Treatment Review, Hormonal Treatment Review

Smoking history

Birth Control/Gynecologic history
Breast Cancer Diagnosis Information

Palpable lump or routine screening

Location (left or right breast, “clock” section, distance from nipple/areola, depth)

Description (histology, ER/PR/Her 2 status)

Additional Genetics (e.g. BRCA status if known)

Family history of breast cancer
In addition to the standard of care information: You will be asked to complete
ECOG Performance Status Score (a measure of your physical abilities/activity)
Cosmetic Appearance Score (a measure of your satisfaction of the appearance of your breast 
following surgery, rated by you and your doctor)
FACT B Quality of Life Questionnaire (a quality of life tool measuring quality of life and 
wellbeing)
The following tables give an example of when these are assessed.
Please remember that participation is voluntary and if at any time you decide you do not wish to 
participate you may withdraw or opt not to complete questionnaires. This decision will not affect 
the treatment or care that you receive.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 5 of 10
Paul Dale, MD
Cohort A
Initial
Operative 
Visit
Follow-
Up # 1
Follow-
Up # 2
Follow-
Up # 3
Follow-
Up # 4
Follow-Up 
# 5 - 12
Prior
to
IORT
IORT
6M*
Post
IORT
12M*
Post
IORT
18M*
Post
IORT
24M*
Post
IORT
36M -120 
M*
Post
IORT
Demographics
X
HTa/WT/BMI
X
X
X
X
X
X
X
Vital Signs
X
X
X
X
X
X
X
History & 
Physical
X
X
X
X
X
X
Breast 
Evaluationb
X
X
X
X
X
X
Imaging 
Reviewc
X
X
X
X
X
X
Medication 
Review
X
X
X
X
X
X
Hormonal 
Therapyd
X
X
X
X
X
Pathology 
Reviewe
X
X
X
Treatment 
Review
X
X
X
X
X
X
Imaging 
Review
X
X
X
X
X
X
QOL – FACT 
B
X
X
X
X
X
X
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 6 of 10
Paul Dale, MD
Cohort B
Initial&
Follow-
Up 
# 1&
Follow-
Up
 # 2
Follow-
Up
 # 3
Follow-
Up
 # 4
Follow-Up 
# 5 - 12
Post
IORT
6M*
Post
IORT
12M*
Post
IORT
18M*
Post
IORT
24M*
Post
IORT
36M -120 
M*
Post
IORT
Demographics
X
HTa/WT/BMI
X
X
X
X
X
X
Vital Signs
X
X
X
X
X
X
History & Physical
X
X
X
X
X
X
Breast Evaluationb
X
X
X
X
X
X
Imaging Reviewc
X
X
X
X
X
X
Medication Review
X
X
X
X
X
X
Hormonal Therapyd
X
X
X
X
X
Pathology Reviewe
X
X
Treatment Review
X
X
X
X
X
X
Imaging Review
X
X
X
X
X
X
QOL – FACT B
X
X
X
X
X
X
Risks
There are no foreseeable physical risks for participating or not participating in this research.
There are no additional tests that will be performed because of your participation in the study. 
However, your participation may involve additional information being asked of you and involve 
research staff that would not normally be involved in your care. This additional involvement may 
affect your privacy and confidentiality. All efforts will be taken to keep your information 
confidential and private. Your identity will be protected as much as possible and a study 
identification will be generated to protect your identity. The information obtained will be secured 
in your medical record, a copy in the Oncology Research Office and in a password protected, 
limited access database.
This participation may also prolong your visits in order to complete additional questionnaires.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 7 of 10
Paul Dale, MD
Benefits
There are no additional benefits to you from participating in this study. Information that is 
collected may benefit others in the future if the research produces information that leads to 
practice change. This benefit is unknown at this time.
Cost and Payment
There is no cost to participate in this research study. You will not receive a bill, nor will your 
insurance provider for your participation. You will be responsible for your treatment costs and 
doctor’s visits. Please contact your doctor’s office to determine costs of care, and your insurance 
company to determine their responsibility.
You will not receive any payment for participating in this research study.
Alternative Treatments
The treatment that you receive is not determined by this research study, it is determined by an 
informed decision you have made with your doctor. Your doctor may have offered or may offer 
treatment alternatives. Your choice to participate in this study will not alter your treatment 
choices nor effect the treatment choices available to you.
Please discuss your treatment choices with your doctor.
Participant Responsibilities
The researchers thank you for considering this research study. To ensure that the information that 
is obtained and the results of the study are of the highest quality the researchers ask that you are 
open and honest in answering any questions that your doctor or their staff asks. In addition, when 
answering the quality of life questionnaire there is no wrong or right answer, there is only the 
answer that you feel is the most appropriate at the time you are answering the question. This may 
change from visit to visit. That is to be expected.
Please keep all appointments that are scheduled. If you are unable to attend an appointment, 
please let your doctor know prior to the appointment, and reschedule at your earliest 
convenience.
Your Rights
Participating in this study does not alter or change your legal rights in any way. You maintain all 
your rights. You have the right to review your medical record and should consult your doctor’s 
office for their policy and procedure to access your records.
You have the right to participate or not participate in this study. You also have the right to 
withdraw from this study at any time. Any information that was obtained up to that point will be 
able to be used but no further information will be collected.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 8 of 10
Paul Dale, MD
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator using the contact information listed on the first page of this consent form.
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chair of the IRB at 
 or the 
Research Subject Advocate at 
You will be given a copy of this signed consent form. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search this Web site at any time. 
AUTHORIZATION TO USE AND DISCLOSE YOUR PROTECTED HEALTH 
INFORMATION
In this research study, any new information we collect from you and/or information we get from 
your medical records or other facilities about your health or behaviors is considered Protected 
Health Information. The information we will collect for this research study includes: all 
information in your medical record, such as results of physical examinations, medical history, lab 
tests, or certain health information indicating or relating to a particular condition.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with the health care 
operations of Atrium Health, Wake Forest University Health Sciences, and their respective 
affiliated entities. 
We will take steps to keep your Protected Health Information private. We will store records of 
your Protected Health Information in a cabinet in a locked office or on a password protected 
computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
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Paul Dale, MD
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and Atrium Health Facilities; representatives from government agencies such as the 
Food and Drug Administration (FDA) or the Office of Human Research Protections (OHRP), the 
Department of Health and Human Services (DHHS) and similar agencies in other countries.  
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs, 
videotapes, audiotapes or other recorded media which identify you unless we have your written 
authorization.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for an indeterminate period of time. This authorization does not 
expire.
You can tell Paul Dale, MD that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
Paul Dale, MD
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Atrium Health Navicent / IORT
Page 10 of 10
Paul Dale, MD
Future Studies
This study may lead to other research opportunities. There may be new developments that the 
researchers discover. We would like to request your permission to contact you in the future 
should the opportunity arise. Please indicate below by circling your answer.
I may be contacted in the future to take part in other research?
YES
NO
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):__________________________________
Subject Signature: _____________________________ Date: ________Time:_______ am pm
STATEMENT OF PERSON EXPLAINING CONSENT 
I have carefully explained to the subject the nature and purpose of the above study.  There has 
been an opportunity for the subject to ask questions about this research study.  I have been 
available to answer any questions that the subject has about this study.
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent Signature:____________________________ Date:___________
  Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00092014
Meeting Date Approved 6/29/2023          
Version Valid Until: 1/10/2024

Page 1 of 2: Participant/Legal Representative Initials___________ 
Authorization to Use/Disclose Protected Health Information for Research Purposes
FOR
Prospective Registry of Intraoperative Radiation Therapy Using 
Low Energy X-ray for Breast Cancer at Medical Center, 
Navicent Health
Explanation and Background
This authorization form is in addition to the informed consent form and provides additional information 
about how your Protected Health Information (PHI) will be used and disclosed for this study. PHI is 
individually identifiable health information that is or has been collected or maintained by the Medical 
Center, Navicent Health or your study investigator and can be linked back to you, the individual participant. 
Your records may include information about your blood samples, physical examinations, medical history, 
and any other data collected or reviewed during the course of the study as described in the consent form.
This form allows the Oncology Research Office staff and the study doctor/s identified in the consent to use 
your records to carry out the study described in the consent form. If you do not sign this form, you cannot 
participate in the study.
By signing this form, you allow the Oncology Research Office staff and study doctor to retrieve records 
from other health care providers that you have seen. You give authorization to any health care provider that 
receives this authorization to release PHI for the purposes of research to the Oncology Research Office and 
your study doctor. This includes all records prior to signing the authorization and following signing the 
authorization.
All of your records, the signed consent form (s) and this form also might be reviewed or copied by the U.S. 
Food and Drug Administration (FDA), by The Medical Center of Central Georgia IRB or by other 
regulatory agencies in this country or in other countries. These agencies might review your records to check 
the information collected in this study, to check how the study was conducted or for other uses allowed by 
law.
Federal and state laws require the study doctor and the Oncology Research Office staff to protect the privacy 
of your records. However, absolute confidentiality cannot be guaranteed because of the need to disclose 
information as described above. In addition, after the study doctor discloses your records to others then the 
law may no longer protect the privacy of the information. The Oncology Research Office staff and your 
study doctor/s will protect the privacy of your records as described in the consent form, if you have 
additional questions please ask your study doctor, the Oncology Research Office staff. If you would like to 
know how the Medical Center, Navicent Health will protect the privacy of your records, you can contact 
the Medical Center of Central Georgia IRB at 
You have the right to see and copy your records related to the study for as long as the study doctor has this 
information in his or her possession. 
This authorization does not have an expiration date. If you do not cancel this authorization, then it will 
remain in effect indefinitely.
WFU School of Medicine 
Institutiona  Revie  Boar  
I B Number:IRB00092014
Mee ing ate Appr ved 1/11/
          
Ver ion V lid U til: 1/10/2024

Page 2 of 2
You can cancel this authorization at any time by giving a written notice to the study doctor.
If you cancel this authorization, then you no longer will be able to participate in the study. If you cancel 
this authorization, then the study doctor will no longer use or disclose your records unless the study doctor 
needs to do so in order to preserve the scientific integrity of the study.
AUTHORIZATION
I authorize the release of any/all of my medical records and health information including:

Old records, current records, and future records,

Office notes,

Consultation notes,

Operation notes,

Procedure noted,

Progress notes,

Imaging reports (MRI, X-ray, CT, PET, mammogram etc.),

Laboratory reports,

Genetic reports,

Pathology reports,

Medication administration records, and

Any other records needed for this study, including my signed consent form and this authorization 
form,
to the study doctors, the FDA, The Medical Center, Navicent Health, The Medical Center of Central 
Georgia IRB and other regulatory agencies as described above.
By signing this form, I have not given up any of my legal rights as a research participant. I understand that 
I will receive a signed copy of this authorization for my records.
_____________________________________________
Printed Name of Participant
_____________________________________________
____________
Signature of Participant
Date
I certify that under state law I am the legally authorized representative of the Participant named above and 
that I am authorized to sign this form to release the Participant's medical records and health information 
as described above.
_____________________________________________
Printed Name of Legal Representative
_____________________________________________
_____________
Signature of Legal Representative
Date
_____________________________________________
Name of person obtaining authorization
_____________________________________________
____________
Signature of person obtaining authorization
Date
WFU School of Medicine 
Institutiona  Revie  Boar  
I B Number:IRB00092014
Mee ing ate Appr ved 1/11/
          
Ver ion V lid U til: 1/10/2024