Development and Testing of an Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study
Conditions: Breast Cancer
Sponsor: University of Chicago

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Protocol Narrative 
DEVELOPMENT AND TESTING OF AN ACCURATE, RAPID AND INEXPENSIVE 
MRI PROTOCOL FOR BREAST CANCER SCREENING--A PILOT STUDY 
 
Principal Investigator: 
Hiro Abe, MD, Dept. of Radiology 
 
Co-Investigators: 
Gregory Karczmar, PhD, Dept. of Radiology 
Kirti Kulkarni, MD, Dept. of Radiology 
Deepa Sheth, MD, Dept. of Radiology 
Olufunmilayo Olopade, MD, Dept. of Medicine 
Gillian Newstead, MD, Dept. of Radiology 
Milica Medved, PhD, Dept. of Radiology 
 
Address: 
University of Chicago 
Dept. of Radiology 
5841 S Maryland, MC 2026 
Chicago, IL 60637 
Telephone: (773) 702-2781 
 
1. 
BACKGROUND 
 
X-ray mammography has significantly reduced breast cancer mortality. However, even 
with mammography, many breast cancers are not detected until they are advanced, and 
illness and death due to breast cancer is a major problem. The best way to control breast 
cancer is to detect it at an early stage when it is relatively easy to treat. MRI has potential 
to significantly improve sensitivity to cancer, and detect many cancers years earlier than 
mammography, especially in women with dense breasts. Given the great sensitivity of 
MRI, it is likely that properly designed MRI screening would detect almost all invasive 
cancers and many pre-invasive cancers at an early stage, resulting in tremendously 
decreased mortality and illness. Effective MRI-screening would have an exceptional 
impact in the region surrounding the University of Chicago Medical Center, where rates 
of breast cancer are unusually high, with an especially high prevalence of aggressive 
breast cancer. If MRI screening can identify cancers several years earlier than 
conventional methods – with very few ‘false positives’ - this would have tremendous 
benefits for patients. 
 
Mammography is not very effective in women with dense breasts and these women 
currently do not have good options for screening. Even in women with normal breast 
density – mammography often does not detect cancers until they are fairly large. It would 
be much better to detect cancer early when it is easier to cure. This is especially 
important for women who are at high risk for aggressive breast cancer. MRI has very 
high sensitivity, and has potential to detect cancer earlier than conventional 
mammography [1]. Sensitivity of MRI is not affected by breast density [1]. However, 

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there are concerns that MRI lacks the specificity required for screening large numbers of 
women, and will generate an unacceptable number of false positives, producing 
unnecessary stress, inconvenience, and expense. In addition, there are concerns that even 
if the accuracy of MRI can be significantly improved, MRI is too expensive for screening 
in the general population. 
 
Routine screening for breast cancer with X-ray mammography has significantly reduced 
morbidity and mortality [1], and clearly demonstrated the benefits of early detection. 
While X-ray mammography is effective for many women – there is concern that it does 
not provide adequate screening for large groups of women. In women with dense breasts, 
the sensitivity of mammography to early cancers is reduced by 30-50% [5, 6]. This is 
particularly problematic because women with dense breasts are at higher risk for 
aggressive breast cancers [7]. In fact, there is concern that for all women at increased risk 
for aggressive breast cancer, e.g. triple negative breast cancer, X-ray mammography does 
not always detect cancer early enough [1]. Much earlier detection is likely to substantially 
decrease morbidity and mortality. 
 
2. 
PURPOSE/HYPOTHESIS 
 
We propose to test an innovative MRI breast cancer screening protocol in women with 
mammographically dense breasts as well as other women with moderately increased 
cancer risk. MRI, combined with other methods of risk assessment, has potential to 
significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases 
at a much earlier stage, with far fewer interval cancers than mammography [8, 9]. 
Previous tests of MRI sensitivity show that this screening could significantly increase the 
likelihood of detecting invasive cancers resulting in decreased mortality from breast 
cancer [1]. Effective MRI-screening would have an exceptional impact in the region 
surrounding the UC Medical Center, where rates of breast cancer are unusually high, and 
where the prevalence of aggressive breast cancer is also very high. If MRI screening can 
identify breast cancers, particularly the most aggressive subtype of breast cancer, several 
years earlier than conventional methods, this would have tremendous benefits for 
patients. 
 
We propose to develop fast, accurate, quantitative, and inexpensive MRI screening 
methods that can easily be implemented in routine clinical practice. This research will 
build on innovative work from this team that has significantly advanced breast MRI, 
including dynamic contrast enhanced MRI of the breasts. This is an opportunity for the 
University to have a significant impact, initially in our immediate neighborhood, and 
eventually nationally and internationally. This is an area where the University should lead 
because of the devastating effect of breast cancer in south Chicago. 
 
The specific purpose of the study is as follows: 
 
1. Develop an efficient, quantitative MRI-screening protocol, less than 15 minutes in 
duration. Evaluate signal-to-noise ratio and reproducibility in 10 volunteers with 
dense breasts. 

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2. Scan approximately 50 women with mammographic or sonographic findings that 
require biopsy using the short MRI protocol (15 minutes), to establish reasonable 
cutoffs for MRI parameters derived from the short protocol, that are likely to 
identify benign and malignant lesions with high sensitivity. 
 
3. In partnership with the Cancer Risk Clinic and the Breast Center, we will identify 
and recruit 150 women with dense breasts and/or intermediate risk of breast cancer 
who will also undergo the short MRI protocol. 
 
4. Perform a reader study to evaluate false positive rate, based on the cutoffs 
established in women with biopsy proven benign and malignant lesions. 
 
5. Perform quantitative analysis to determine standard DCEMRI protocols including 
Ktrans (the rate constant for contrast media uptake; [2-4]). In addition, we will 
test novel parameters that can be extracted from ultrafast datasets; initial time of 
enhancement in parenchyma and suspicious lesions, new approaches to 
calculating Ktrans and the arterial input function based on early enhancement, and 
number and size of arteries feeding suspicious lesions and rate of enhancement of 
those blood vessels. These markers can be accurately calculated from ultrafast 
imaging but cannot be accurately measured with conventional methods. 
Determine the rate of false positives based on the cutoffs for each of these 
parameters determined from the study of women with confirmed breast cancer 
(‘2’ above). 
 
6.  Suspicious lesions will be defined by the clinical interpretation of the breast MRI 
images performed by the attending breast radiologist. Based on the radiologist 
determination that the MRI findings are suspicious (these findings include 
masses, non-mass enhancement and foci), suspicious lesions will be assigned a 
Bi-Rads code specifying whether additional work up or biopsy is 
necessary. These are BiRads codes 0, 4 and 5. False positive diagnosis should be 
minimized as all attending physicians reading breast MRI at this institution are 
fellowship trained in breast imaging. 
 
 
3. 
RECRUITMENT PLAN 
 
We plan to enroll approximately 200 subjects in total. 
1. We will scan approximately 200 women who meet the entry requirements 
described below. This number may vary slightly because we will scan women 
with suspicious findings on mammography until we find 30 cancers, verified by 
the subsequent biopsy. Therefore it is not possible to report the exact number of 
women who will be in this group. 
2. We will scan 150 healthy women with dense breasts and/or women who 
have risk of breast cancer that is average of higher. 

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Dense breasts are defined as categories C and D, defined in the American College of 
Radiology (ACR) BiRads manual. We will also follow ACR guidelines for risk 
categories. The ACR defines intermediate risk as those patients with a lifetime risk 
for breast cancer of 15%-20%. This includes women with a personal history of 
breast cancer, history of proven lobular neoplasia, atypical ductal hyperplasia or 
other women with 15%-20% risk based on risk models. 
 
 
 
 
4. 
ELIGIBILITY 
Inclusion criteria: 
 Women who have a mammographically and/or sonographically identified finding 
that will require image guided biopsy. 
 OR 
 For the ‘screening group’ we will recruit women between ages of 30 –70 who 
have above10% lifetime risk of breast cancer or who have dense breasts (based 
on BIRADS score) but who currently do not have any diagnosis of breast cancer. 
 We will select women for the screening group and the group of women with 
suspicious mammographic findings so that the two groups are well-matched. Our 
target is to match the percentage of parous and non-parous women, and 
premenopausal and post-menopausal women. In addition we will match the age 
distribution in the two groups. 
Exclusion criteria: 
 Women with a history of adverse reactions to contrast media. 
 Women who are pregnant. 
 Patients who are demonstrated to be at risk for an allergic reaction or nephrogenic 
systemic fibrosis (NSF) will be excluded from the study. Details as to how 
patients are evaluated for these risks are provided below (see ‘Potential Risks’). 
 
5. 
STUDY DESIGN 
Enrollment: 
1. Approximately 50 women with suspicious findings on mammography who are 
scheduled for biopsy will be recruited. We expect this will result in 30 cancers 
and 20 benign lesions. When possible, we will perform MRI scans before the 
biopsy so that biopsy will not affect MRI results. Lesions will be classified as 
benign and malignant based on the subsequent biopsy. We will continue 
scanning until we have scanned 30 women with biopsy-confirmed malignancy. 
We estimate that 

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this will require a total of 50 scans, but the total number may turn out to be 
slightly higher or slightly lower. 
 
2. We will also recruit 150 women with dense breasts and/or women who 
have intermediate risk of breast cancer for this study. 
 
MRI scans: 
 
Women will receive a mammogram and an MRI-screening exam. The MRI screening 
exam will consist of calibration scans, bilateral T2-weighted scans, and a DCEMRI scan. 
The duration of the entire protocol will be less than 15 minutes. 
 
Ground truth assignment: 
 
Assignment for the group who will have biopsy based on mammogram and/or 
ultrasound: 
 
a. Surgical pathology will be the gold standard for these patients for the lesions 
previously identified on mammogram or ultrasound. 
b. Any additional lesions detected on MRI will follow the assignment as below 
for the screening group. 
 
Assignment for the dense breast/intermediate risk group: 
 
a. Women who have no cancer found on MRI will be classified as having no cancer. 
b. If additional lesions are deemed suspicious on MRI and these lesions are biopsied, 
they will be classified as benign or malignant based on biopsy surgical pathology 
results. 
c. If additional lesions are found on MRI but physicians elect not to biopsy based on 
the findings, these lesions will be assumed to be benign for the purposes of this 
study. In some cases, women may be referred for follow-up exams, e.g. in 6 
months. In these cases, lesions that are still not biopsied after 6 month follow-up 
will be assumed to be benign for the purposes of this study. 
 
 
Reader Study: 
 
The T2-weighted scans and high resolution post contrast T1-weighted scans will be 
evaluated by Radiologists using conventional diagnostic procedures. Radiologists will 
also evaluate ultrafast scans to identify regions with anomalously rapid enhancement, or 
abnormally enhancing blood vessels in ultrafast images. Based on this evaluation they 
will assign a probability of malignancy, on a scale from 1 – 10. Three independent 
readers will evaluate images and assign a probability of malignancy. We will calculate 
ROC curves for each of the 3 readers to assess 1) variability of Reader’s ‘probability of 
malignancy’ scores 2) AUCs for Radiologists compared to the quantitative parameters 
described above. The Reader study is an exploratory aim and the study is not powered to 
perform this analysis with reasonable statistical confidence. The goal is simply to obtain 

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a preliminary assessment that can provide a basis for future studies with a larger number 
of patients and readers. 
 
Statistical Power: 
 
Thirty women with biopsy-confirmed breast cancer and between sixty and seventy 
controls (women with dense breasts and/or moderate breast cancer risk, frequency- 
matched by parity, age, and menopausal status; control group also includes some women 
with biopsy-proven benign lesions) will be scanned using the short MRI protocol. 
Receiver Operating Characteristic (ROC) curves and statistics will be constructed for 
several MRI parameters of interest: Ktrans, initial time of enhancement in parenchyma 
and suspicious lesions, new approaches to calculating Ktrans and the arterial input 
function based on early enhancement, and number and size of arteries feeding suspicious 
lesions and rate of enhancement of those blood vessels. The primary endpoints of this 
study are Ktrans and ‘initial time of enhancement’. Optimal diagnostic thresholds will be 
determined for each parameter, where the optimal threshold for a given parameter is 
defined as the parameter value which has highest sum of specificity and sensitivity over 
all possible thresholds with specificity > 80%. We will also test whether the area under 
the curve (AUC) for each parameter exceeds 60%. 95% confidence intervals will be 
constructed for the AUC for each curve and the sensitivity and specificity of each optimal 
threshold. For our two primary endpoints (Ktrans and initial time of enhancement), our 
sample of 200 subjects (30 cases + 170 controls) is large enough to detect AUCs of 74% 
(i.e., a difference of 14%) at the 5% significance level. 
Thresholds determined in this pilot study will later be validated in a larger cohort – this is 
the subject of an RO1 proposal to be submitted soon. In the future cohort, we will 
construct covariate-adjusted ROC curves that will be used to calculate thresholds, 
specificities, and sensitivities for patients with different breast cancer risk factors (Gail 
scores, family history, etc.). 
 
We will also produce ROC curves for each reader in the ‘reader study’ to obtain a 
preliminary estimate of how standard evaluation of abbreviated MRI datasets compare 
with the quantitative analysis described above. However, this is an exploratory aim of 
the study and the study is not powered to evaluate the statistical confidence of these 
measurements. 
 
6. 
PROCEDURES TO WHICH HUMANS WILL BE SUBJECTED: 
 
Patients with lesions detected on mammography or ultrasound: 
 
Patients with scheduled biopsy will undergo the research MRI prior to their biopsy. At 
the time that the biopsy is recommended, the radiologist will identify the patient as one 
who will be having a biopsy and could qualify for research MRI. The breast care 
treatment teams (high risk clinic, surgery clinic) will contact the Radiology Research 
Coordinator if they have a patient that they believe could be eligible for the study. Once 
identified, the patient’s name and MRN will be given to the research coordinator. She 
will be contacted by phone regarding the research study by the research coordinator. The 

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study will be explained to her, and she will be asked about her interest in participating. 
Questions, if any, will be answered. If interested, she will be scheduled in an MRI time 
slot. Biopsy patients will be scheduled for their MRI in the same visit unless they prefer 
otherwise. Prior to the MRI, they will be asked to read and sign the informed consent 
document by the research coordinator. 
 
Data will be collected from the subjects regarding their race and ethnicity, age, weight, 
height, menopausal status, last menstrual cycle date. 
 
All routine precautions will be taken prior to the MRI scans (screening for metallic or 
electronic (e.g., pace-maker) implants, removal of all metallic objects, etc.). 
 
Patients with dense breasts and those referred for intermediate risk: 
 
Women age 30-60 with dense breasts presenting for screening mammography are one of 
the target populations. The radiologist will identify scheduled mammography screening 
patients who are known to have mammographically dense breasts based on prior 
screening mammograms. Once identified, the patient’s name and MRN will be given to 
the research coordinator. In cases identified by the Breast Center or Cancer Risk Clinic 
as intermediate risk, the research coordinator will be contacted about the patient. 
 
The patient group who has dense breasts will be recruited by the Radiology Research 
Coordinator. Recruitment will be based upon the fact that the patient, who is scheduled 
for a screening mammogram, is known to have dense breasts on a previous years 
screening mammogram. Based on her known breast density, she will be eligible for 
recruitment into the study. Once a patient with dense breasts or intermediate risk is 
identified, she will be contacted by phone or in person during a clinic visit regarding the 
research study by the research coordinator. The study will be explained to her, and she 
will be asked about her interest in participating. Questions, if any, will be answered. If 
interested, she will be scheduled in an MRI time slot. Mammography patients will be 
scheduled for their MRI in the same visit unless they prefer otherwise. Prior to the MRI, 
they will be asked to read and sign the informed consent document by the research 
coordinator. 
 
Data will be collected from the subjects regarding their race and ethnicity, age, weight, 
height, menopausal status, last menstrual cycle date. 
 
1) Patients undergoing a screening or routine diagnostic mammogram will also 
undergo an MRI exam on the same day. The mammography exams will be 
part of standard clinical care, and not acquired specifically for the purpose of 
this study. The MRI exams will be research-only exams. 
2) Blood test of kidney function (standard screening procedure) for breast MRI 
w/contrast is only required if: over 60 years old, have hypertension or 
diabetes. 
 
 
All routine precautions will be taken prior to the MRI scans (screening for metallic or 
electronic (e.g., pace-maker) implants, removal of all metallic objects, etc.). 

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7. 
BENEFIT/PAYMENT 
 
It is possible that participation in an innovative MRI breast cancer screening study may 
help to improve early detection in women with dense breasts and/or women who have 
moderate risk of breast cancer. Also, the additional MR images may provide information, 
which may influence treatment. For example, abnormal tissue, which was not detected by 
mammography, may be detected by MRI. It is possible that participation may lead to the 
detection of an early breast cancer that was not visible on mammography. 
 
Subjects will be paid $75 for participation in this study.  In addition they will receive a 
coupon for lunch and a parking pass. 
 
8. 
COSTS 
 
The cost of the research MRI scans will be covered by the study. If clinically significant 
findings are noted on the MRI, they will be reviewed/processed as standard of care and if 
the patient selects to do follow-up studies and/or treatment, the patient and/or the 
patient’s insurance will be responsible for those costs. 
 
9. 
POTENTIAL RISKS 
 
A) The detection of abnormalities not visible using conventional x-ray 
mammography. The experimental scans do not carry any risks to the patients 
beyond those posed by the clinical MRI exam. The primary risk of clinical MRI is 
that some of the lesions detected by MRI are likely to be benign. If suspicious 
lesions are detected by MRI they may be biopsied and in some cases the lesion will 
prove to be benign and the biopsy will have been unnecessary. In this case the 
patient will have unnecessary discomfort, anxiety, and expense. However, in the 
cohort of women at an elevated risk for breast cancer, the risk of false-positive is 
considered to be justified by the benefits of finding cancers at an early stage when 
they can be easily treated. 
 
B) Allergic reactions to the contrast media: Most study subjects will be injected with 
the standard dose of a magnetic resonance contrast agent. Nationally, MRI contrast 
agents are used in tens of thousands of patients each year. Current research findings 
suggest that there are fewer than four serious allergic reactions per year. A small 
percentage of patients (1% - 5% of those injected) suffer an allergic reaction to this 
agent. These reactions are usually mild (e.g., headache, nausea, vomiting, 
hypotension) and resolve spontaneously after a few minutes or hours. However, in 
very rare cases the reactions can be severe and require hospitalization. Several deaths 
have been reported which may have been associated with the use of gadolinium 
contrast agents. This is difficult to verify because the patients involved were very ill 
before receiving contrast injections. MRI contrast agents may also cause mild and 
transient elevations in the levels of certain chemicals in the blood (e.g., iron and 
bilirubin). Study subjects will be questioned regarding their history of allergic 

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reactions before undergoing MRI exams. When contrast agent is administered, the 
patients are monitored by the MRI technician over a video and audio connection. 
The patients are also given a ‘panic button’ that they can activate at any time to alert 
the technician. If there is a reaction to the contrast agent, the on-site radiologist will 
examine the patient and direct further treatment. If necessary, emergency staff will 
come to the site to administer first aid. This is standard procedure that is followed for 
clinical and research subjects alike. The catheter that is used to inject the contrast 
medium will be inserted intravenously by an experienced physician, nurse, or 
technologist. Insertion may cause some bruising and or bleeding which may result in 
some discomfort. 
 
C) Nephrogenic systemic fibrosis (NSF): NSF is a very rare but very serious condition 
that can lead to disability or even death. It has been associated with the use of non- 
ionic gadolinium-based MRI contrast agents, and is thought to be the result of 
gadolinium toxicity due to slow clearance by the kidneys. NSF has only been 
documented in patients with severe renal impairment. After 2007, routine screening 
protocols have been implemented to identify such patients prior to their MRI, which 
resulted in a steep drop in the number of reported cases. At our hospital, this 
protocol is implemented via a questionnaire that is designed to identify patients at 
risk for compromised kidney function. For patients identified as such, the medical 
record will be searched for a recent kidney function test, or a new test will be 
ordered that day. If a recent test is not available, or if a glomerular filtration rate 
(GFR) value lower than 60 is measured, the patient will not be recruited for the 
study. 
 
D) Pregnancy: Although we are unaware of any such injuries caused by the contrast 
agents used in the present study, the remote possibility of fetal injury or even fetal 
death does exist. Therefore, pregnant women will be excluded from this study. 
Prospective study participants of childbearing age will be told about the potential 
risks to a fetus. 
 
E) Breastfeeding: The contrast agent used in the study may transfer to the breast milk, 
exposing a nursing child to a small but unnecessary risk. Prospective patients, who 
are breast feeding, will not be asked to participate in a contrast-enhanced exam. 
 
F) Sickle cell anemia, hepatic disease or other hemolytic illness, any type of seizure 
disorder or a predisposition toward seizures: For persons with each of these 
conditions, the contrast agent used in the study may slightly increase their risk of 
complications from their condition. Subjects with the above-mentioned conditions 
will not be asked to participate. 
 
G) The presence of devices, implants, or other objects containing metal: Metal 
objects pose a serious risk to all patients undergoing MRI exams. This includes 
internally implanted objects such as surgical clips, bio-support devices (e.g., 
pacemakers), and in some cases artificial joints which contain metal. Patients are 
questioned carefully before MRI imaging to insure that they do not have metal 

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implants. Prospective study participants who have such implants that are not MRI 
safe will be excluded from the study. Patients who have worked in or near machine 
shops and electronics shops are also excluded from the study. In these work 
environments metal slivers may become trapped in the eyes, posing a potential 
hazard if exposed to a strong magnetic field. In addition, metal objects such as heavy 
key chains that are carried into the scan room can cause serious accidents. Patients 
will be cautioned to remove all metal objects before entering the scan room. Access 
to the scan room is carefully controlled to insure that no ferrous metal is 
inadvertently brought in. 
 
H) Exposure to magnetic fields: Apart from its effects on metal objects and implants, 
there are no known negative effects associated with the magnetic fields used to 
produce MRI images. Despite the exposure of millions of people to high-intensity 
magnetic fields in MRI scanners over the last 15 years, and to those generated near 
cyclotrons during the last 50 years, there are no confirmed reports of adverse health 
effects. The radio-frequency (RF) energy that is used to excite the MRI signal may 
in extraordinary circumstances cause heating and burning of tissue. In addition, rapid 
switching of the gradients may cause transient discomfort. In addition, there is a 
remote likelihood of tissue damage when rapidly changing magnetic fields are used. 
As a further protection, even if a higher energy pulse programming protocol were to 
be used in error, the commercial MRI machine that will be used for this study 
(Philips 3T) is equipped with both software and hardware power limiters that prevent 
the execution of pulse sequences in excess of FDA limits. The statistical evidence 
suggests that exposure to excessive RF energy caused by this equipment is, for all 
practical purposes, impossible -- there have been no reports of significant RF injury 
in over one hundred thousand clinical MRI exams. 
 
I) 
Claustrophobia. Some patients may experience claustrophobia during the MRI 
exam due to the limited space available inside the bore of the magnet. Prospective 
participants will be counseled about this possibility before the exam. The magnet is 
equipped with an intercom system enabling study subjects to communicate with the 
operators at any time during the exam. If they report any discomfort during the MRI 
examination they will be removed from the magnet immediately. 
 
J) Blood draw. Some patients may experience mild pain, discomfort, irritation, 
swelling, bruising, and/or redness at the site of the needle stick, or the patient may 
get a light-headed feeling. Rarely, an infection can occur. It is uncommon, but the 
patient may feel faint from the procedure. Care will be taken to avoid these 
complications. 
 
K) Risk of false positive findings: 
Sometimes MRI finds additional areas that need more testing (such as mammograms, 
ultrasound or MRI) in order to determine their cause. In some cases, that further testing 
turns out to be benign (not cancer). If lesions are detected by MRI they may even need to 
be biopsied to determine whether they are benign and the biopsy will have been 
unnecessary. In these cases there will have been unnecessary discomfort, anxiety, and 

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expense. However, the risk of false-positive is considered to be low and justified by the 
converse benefits of potentially finding cancers at an early stage when they can be easily 
treated. All of the standard MR images we obtain during this study will be examined 
carefully by an experienced radiologist. If there is anything suspicious, the radiologist or 
the nurse will contact you and/or your physician and discuss further imaging. 
 
 
 
10. 
ALTERNATIVE PROCEDURES AVAILABLE TO SUBJECTS 
 
Patients can choose not to volunteer for this study. The proposed study is experimental 
and is in no way a necessary part of standard or specialty patient care. The enrollment in 
the study does not affect the patient’s ongoing clinical care. 
 
11. 
REPORTING OF SERIOUS AND UNEXPECTED ADVERSE 
CIRCUMSTANCES 
 
Serious and unexpected adverse experiences will be immediately reported by telephone 
to the University of Chicago IRB. A written report will follow the initial telephone call 
within three working days to the IRB. 
 
12. 
CONFIDENTIALITY 
 
As with all research studies involving the use of clinical data, there is a minimal risk of 
breach of confidentiality. This risk is minimized by the coding/de-identifying of clinical 
data with limited study personnel having access to the code key. Only the PI and 
research staff will have access to study patient information. Names or other unique 
identifiers will not be utilized in any abstracts or manuscripts generated from the data 
obtained in this study. If data is shared with collaborators outside of this study, only de- 
identified data will be shared. All research files and computer databases will be stored in 
secure locations, with access limited to members of the research team. These data files 
will be maintained for at least six years after the study is completed and destroyed and/or 
erased when no longer needed. 
 
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