The Prone to Supine Breast MRI Trial
Phase: NA
Conditions: Breast Cancer
Sponsor: Dartmouth-Hitchcock Medical Center

D17168
Version  05.07.19
i
D17168: The Prone to Supine Breast MRI Trial
Principal Investigator:
Timothy B. Rooney, MD
Co-investigators:
Rebecca A. Zuurbier, MD
Richard J. Barth Jr., MD
Study MRI Technologist-Investigator:
Misty Fox
Statistician:
Tor D. Tosteson
Study Coordinator:
Tanya Perry
Consultants:
Venkat Krishnaswamy, PhD
Keith Paulsen, PhD
Funding:
CairnSurgical, Inc. 
(through a NCI Small Business Innovation Research Program award)

D17168
Version  05.07.19
ii
HISTORY OF CHANGES
Ver. 
05.07.19
Addition of patient-reported outcome questionnaire comparing experience of supine to 
prone MRI.  Minor editorial corrections.  See pages 5, 7 & 11.
Ver. 
08.27.18
Changes to this protocol have been driven by a change in the funding source from in-
house NCCC funds to CairnSurgical, Inc.  
In addition to adding the funding source to the protocol (cover page and referenced on 
page 4), the protocol has been revised to allow de-identified data to be sent to 
CairnSurgical for use in the development of the Breast Cancer Locator.  
The consent form has been revised to reflects these changes.
A Table of Contents has been added to the Protocol along with other minor editorial 
corrections.
Ver. 
5.23.18
1. Method of providing consent prior to surgery changed from email and mail to “mail or 
email.” 
2. The MRI Technician-Investigator has been changed from Kim Krueger to Misty Fox on 
the front page and her title corrected.
3. Reference #1 was updated with complete publication information.
4. Language in sections 9-12 related to multiple sites was removed as study is being 
conducted only at NCCC-Lebanon.
5. Who can arrange for MRI scheduling has been modified as a result of team 
conversations with Comprehensive Breast Program schedulers.

D17168
Version  05.07.19
1
TABLE OF CONTENTS
Abbreviations 
 2
Section 1.  Introduction 
 3
Section 2.  Objectives 
 5
Section 3.  Eligibility criteria 
 5
Section 4.  Treatment plan 
 6
Section 5.  Potential toxicity 
 7
     Section 5.1.  Reporting criteria for UADEs 
 7
Section 6.  Device formulation and preparation 
 9
Section 7.  Endpoints and statistical analysis 
 10
Section 8.  Safety and data monitoring 
 11
Section 9.  Protocol compliance monitoring 
 11
Section 10.  Data transfer 
 11
Section 11.  Record retention 
 11
Section 12.  Human subjects 
 13
Section 13.  Obligations of investigators 
14
Section 14.  References 
 15

D17168
Version  05.07.19
2
ABBREVIATIONS
3D
three-dimensional
BCL
Breast Cancer Locator
CBP
Comprehensive Breast Program 
CCRC
Clinical Cancer Review Committee at the Norris Cotton Cancer Center
CPHS
The Committee for the Protection of Human Subjects at Dartmouth 
College
DCIS
ductal carcinoma in situ
DHMC
Dartmouth-Hitchcock Medical Center
DSMAC
Data Safety Monitoring and Accrual Committee at the Norris Cotton 
Cancer Center
FDA
U.S. Food and Drug Administration
Gd
gadolinium
IRB
institutional review board
MRI
magnetic resonance imaging
NCCC
Norris Cotton Cancer Center
NCI
National Cancer Institute (U.S.)
OR
operating room
SAE(s)
serious adverse event(s)
UADE(s)
unanticipated adverse device effect(s)
US
ultrasound

D17168
Version  05.07.19
3
Section 1.  INTRODUCTION
We have recently developed a device called the Breast Cancer Locator (BCL). The BCL 
(manufactured by CairnSurgical, Inc.) is a 3-D printed, bra-like form which transfers information 
about the location of a breast cancer derived from a supine MRI image to surgeons in the 
operating room. We have utilized BCLs in 19 breast cancer patients and have demonstrated 
that they are safe, easy to use and accurately transfer information about breast cancer location 
to the surgeon (1). 
The Clinical Problem
A potential limitation to the widespread adoption of BCLs to aid surgeons to more 
accurately remove breast cancers is the current requirement that a patient have a supine MRI. 
The current diagnostic standard is a prone MRI. It is inconvenient and costly for patients to 
have a second (supine) MRI at a separate time after the diagnostic prone MRI is completed. 
The purpose of this study is to determine whether one could obtain a supine MRI immediately 
after a prone MRI exam, without a second injection of gadolinium (Gd) contrast material. The 
supine MRI would have to be of sufficient quality to allow the Radiologist to define the tumor 
edges (“segment” the tumor) so that a 3-D image of the tumor can be generated to form the 
BCL. 
In many cases the tumor is identified by the differential uptake of Gd contrast material in 
the tumor compared to non-cancerous breast tissue. In a standard diagnostic prone MRI 
images are completed by 10 minutes after contrast injection. We have searched the literature 
and there is a paucity of information regarding whether the differential uptake observed during 
the 10 minutes after Gd injection is maintained for an additional 10 minutes required to flip the 
patient from a prone to a supine position and obtain additional MRI images. One paper 
demonstrated that use of a special sequence (3D spectral-spatial excitation magnetization 
transfer) did allow delayed tumor delineation (2). We plan to evaluate whether the same 
standard MRI sequences used for the 10 minute images provide the needed discrimination for 
up to 20 minutes.

D17168
Version  05.07.19
4
Preliminary Data
In the course of obtaining supine MRIs on 8 patients with invasive cancer in another study 
(D0928), we obtained delayed images 5-10 minutes after the standard post-contrast images 
were obtained (15-20 minutes after contrast had been injected). We created unique files which 
contained the images obtained in the first 10 minutes and the images obtained 15-20 minutes 
after contrast injection. These files were then provided to 2 study Radiologists in random 
sequence and the Radiologists were asked to segment the tumor. Both Radiologist 1 and 2 
were able to segment the 10 minute images in all patients. Radiologist 1 and 2 were both able 
to also segment the 15-20 minute images in 100% of the cases. 
We quantitated the amount of enhancement (mean signal intensity) at the tumor site and at 
a site of benign fibrous breast tissue in these 8 patients from the images obtained 10 and 15-
20 minutes after contrast injection. As shown in Table 1, there was very little diminution of the 
contrast in the tumor at 20 minutes compared to 10 minutes (no decrease in 5 patients, 
average decrease 5%). There was a slight increase in enhancement in benign breast tissue in 
5 of the 8 patients (average increase 10%). The mean difference between the enhancement in 
the tumor vs benign breast at 10 minutes was 34, and at 20 minutes was 25. In all 7 patients 
who had a differential enhancement of the tumor compared to benign tissue at 10 minutes, the 
differential enhancement persisted at 20 minutes.
Table 1. Contrast enhancement over time in tumor and benign breast tissue
Patient
Contrast in Tumor
Contrast in Benign Breast
.
10’
20’
% change
10’
20’
% change 
1
61
60
-2
42
48
+14
2
85
85
0
32
42
+31
3
55
54
-2
55
53
 -4
4
67
67
0
50
56
+12
5
72
68
-6
40
38
 -5
6
72
77
+7
35
47
+34
7
83
70
-16
62
55
-11
8
162
130
-25
71
80
+13

D17168
Version  05.07.19
5
This limited analysis of data from 8 patients is promising and justifies study of a larger number 
of patients. 
Section 2.  OBJECTIVES
The purpose of this study is to determine whether a supine MRI obtained immediately after 
a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast 
material, would be of sufficient quality to allow the Radiologist to define the tumor edges 
(“segment” the tumor) so that a 3-D image of the tumor can be generated to form a BCL. 
The primary objective is to determine what percentage of cases that can be successfully 
segmented from 10 minute post-contrast prone MRI images can also be segmented using 20 
minute post contrast supine MRI images.
Our secondary objectives are to: 
1. Quantitate the amount of enhancement at the tumor site and in benign breast tissue at 
10 minutes and 20 minutes after contrast injection.
2. Calculate the difference between tumor and benign breast tissue enhancement at 10 
minutes and 20 minutes after contrast injection.
3. Calculate the additional time needed to obtain supine MRI images.
4. Quantify the perceived comfort level of the prone and supine MRI as reported by 
participants.
Section 3.  ELIGIBILITY CRITERIA
1. Age > 18 years.
2. Female gender.
3. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ. 
4. Tumor size at least 1 cm in diameter as visualized on mammogram or US.
5. A diagnostic breast MRI is considered to be clinically indicated.
6. Ability to voluntarily provide informed consent to participate prior to any study-related 
assessments/procedures being conducted.

D17168
Version  05.07.19
6
Exclusion Criteria
1. Absolute contraindication to MRI, including presence of implanted electrical device. 
(pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
2. Severe claustrophobia.
3. Contraindication to use of gadolinium-based intravenous contrast, including life- 
threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
4. History of median sternotomy.
5. Pregnancy.  Patient attestation that they are not pregnant will be acceptable. 
6. Patients who have received neoadjuvant chemotherapy.
An eligibility worksheet will be completed for each patient prior to enrollment and will be signed 
and dated by a study investigator.
Section 4.  TREATMENT PLAN
Patients with a percutaneous core biopsy demonstrating invasive carcinoma or ductal 
carcinoma in situ who are being scheduled for a diagnostic bilateral prone breast MRI based 
on the standard criteria utilized by the Comprehensive Breast Program (CBP) of the NCCC 
(surgical provider preference) will be invited to participate in the study. This invitation to 
participate will be done by the study MRI technician-investigator after the patient is informed by 
the CBP that the diagnostic prone MRI is clinically indicated. If a patient indicates they are 
willing to participate, they will be informed that they will receive a consent form by mail or email 
for them to review prior to the date of the MRI. At this time the MRI technician-investigator will 
complete the eligibility worksheet and contact the study coordinator. 
Upon receipt of the eligibility worksheet, the MRI Technologist or Study Coordinator will: 1) 
contact the CBP to ensure the Radiology MRI include extra time for the supine MRI, and 2) 
send the patient the consent form by mail or email. 
When the patient comes to DH for the MRI, prior to the MRI being performed, the study 
MRI technician/investigator will sign and collect the consent form signed by the patient. If the 
patient has additional questions about the study when they come for the MRI, the study MRI 

D17168
Version  05.07.19
7
technician/investigator will answer the questions. The original signed consent form will be 
given to the study coordinator and a copy will be given to the patient. The study coordinator will 
be contacted and will enroll the patient on the study, prior to the supine MRI being performed. 
Prior to starting the prone MRI, the study MRI technician/investigator will explain to the 
patient and practice with the patient the steps needed to transition from the prone to the supine 
MRI, so as to facilitate a timely transition. The supine breast MRI consists of 2 key sequences:
1) T1 pre-Gd, large field-of-view, without fat saturation: for skin surface rendering.
2) T1 dynamic pre- & post-Gd, with fat saturation: to visualize the tumor and co-
register to the surface rendering.
The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced 
bilateral breast MRI. The time from injection of Gd to completion of the prone MRI sequences 
will be noted. Immediately after the prone MRI is completed, the patient will be repositioned for 
the supine MRI. T1, dynamic (post-Gd) sequences will then be performed (with the time post-
injection noted), followed by a fat saturated sagittal sequence, and finally by T1 large field of 
view sequences without fat saturation. 
Following the completion of both MRIs, participants will be asked to rate their comfort with 
each method on a scale from 0-5 using a single-page questionnaire. 
Section 5.  POTENTIAL TOXICITY
Supine MRIs are administered according to standard-of-care practice for prone breast MRI 
and represent no more additional risk than would be experienced by women receiving these 
exams as part of their (non-research) breast care.  The risk of contrast enhanced MRI is very 
low, reflecting the minute risk of life-threatening allergy and development of nephrogenic 
sclerosis related to gadolinium-based intravenous contrast.  Patients deemed to be at higher 
risk for gadolinium-induced nephrogenic sclerosis because of compromised renal function will 
not be eligible for participation.  
5.1 Reporting Requirements for Adverse Events and Unanticipated Adverse Device 
Effects (UADEs)

D17168
Version  05.07.19
8
Adverse events and unanticipated problems will be reported to the Principle Investigator, 
Dr. Timothy Rooney as soon as possible. The Sponsor-Investigator complies with all DHHS 
and FDA regulations pertaining to AE and UADE reporting, as well as the Dartmouth 
Committee for the Protection of Human Subjects (CPHS) reporting policies. These policies are 
found at http://www.dartmouth.edu/~cphs/docs/aedsmmemo.pdf using their CPHS – UPIRSO, 
SAE, UADE Reporting Form found at http://www.dartmouth.edu/~cphs/tosubmit/forms/. 
Unanticipated adverse device effect (UADE) is defined as any serious adverse effect on 
health or safety, or any life-threatening problem or death, caused by or associated with an 
investigational device.  Unanticipated adverse device effects (UADEs) must be reported as 
soon as possible but no later than 10 working days after the local investigator learns of the 
effect.
Adverse effects to be reported to the Sponsor-Investigator are: any adverse experience, 
defined as any untoward or unfavorable medical occurrence in a human subject, including any 
abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or 
disease, temporally associated with the subject’s participation in research, whether or not 
considered related to the subject’s participation in the research), that is considered:
•
Serious: Death; a life-threatening adverse drug experience; inpatient hospitalization or 
prolongation of existing hospitalization; a persistent or significant disability or incapacity; 
or a congenital anomaly or birth defect; and
•
Unexpected:  Any adverse experience, the specificity or severity of which is not 
consistent with the current investigator brochure or consent form; and
•
Possibly related:  There is a reasonable possibility that the incident, experience, or 
outcome may have been associated with the procedures involved in the research.
The following definitions will be used to assess causality:
•
No:
The clinical adverse event is definitely unrelated to study procedures  (e.g., does 
not follow a reasonable temporal sequence from study procedure, present prior to 
procedure, etc.)
•
Unlikely:
The study procedures do not have any reasonable association with the 
observed experience; however, relationship cannot be definitely excluded.
•
Possibly:
The connection with study procedures appears feasible, but cannot be 

D17168
Version  05.07.19
9
excluded with certainty (e.g., follows a reasonable temporal sequence from procedure, 
but may also be related to other known factors).
•
Probably:
The clinical experience appears related to the study procedures with a 
high degree of certainty (e.g., follows a reasonable temporal sequence from procedure  
and abates upon termination of the procedure, cannot be reasonably explained by 
known characteristics of the patient’s clinical state or other modes of therapy 
administered to the patient, etc.)
An unanticipated problem involving risks to subjects or others is defined as any incident, 
experience, or outcome that meets each of the following criteria:
•
Unanticipated in terms of nature, severity, or frequency given: (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and consent document; and (b) the characteristics of the 
subject population being studied; and
•
Possibly related to participation in the research means there is a reasonable possibility 
that the incident, experience, or outcome may have been associated with research 
participation; and
•
The problem suggests that the research places subjects or others at a greater risk of 
harm (including physical, psychological, emotional, economic, legal, or social harms) 
than was previously known or recognized.
Copies of each report and documentation of IRB notification and receipt will be kept in the 
Clinical Investigator’s study file.
The Dartmouth Lead Investigator will report information on participants to the Data Safety 
Monitoring and Accrual Committee (DSMAC) of the Norris Cotton Cancer Center.
Section 6.  DEVICE FORMULATION AND PREPARATION
Supine MRI images will be obtained on 1.5T or 3T MRI scanners at DH using  
manufacturer approved body coils and sequences that are designed to obtain both breast 
surface contour (T1 pre-Gd, large field-of-view, without fat saturation) and breast tumor (T1 

D17168
Version  05.07.19
10
dynamic, with fat saturation) signatures. These coils will be positioned over the patient using a 
plastic support structure that minimizes breast compression. 
Section 7.  ENDPOINTS AND STATISTICAL ANALYSIS
The purpose of this study is to determine whether a supine MRI obtained immediately after 
a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast 
material, will be of sufficient quality to allow a Radiologist to define the tumor edges (“segment” 
the tumor) so that a 3-D image of the tumor can be generated to form a BCL. 
The specific primary objective is to determine what percentage of cases can be 
successfully segmented from 20-minute post-contrast supine MRI images. Two study 
Radiologists will independently attempt to segment the supine MRI images on all patients. 
They will have access to mammogram, US and prone MRI images from each patient to 
facilitate segmentation. A segmentation will be defined as successful if the Radiologist, using 
their clinical judgement and the images provided, can confidently identify the location of the 
tumor and delineate its edges on the supine MRI. The results for each patient will be binary: 
either a segmentation can or cannot be performed. Our main outcome measure will be the 
percentage of cases that can be successfully segmented from the supine MRI images by both 
study Radiologists. 
We hypothesize that 80% of the supine MRI images obtained at 20 minutes after contrast 
will be successfully segmented by both Radiologists.  For this descriptive study of a 
dichotomous variable, a sample size of 62 patients will allow us to say with 95% confidence 
that the true percentage of supine MRIs that can be segmented is 80% +/- 10%. 
Our secondary objectives are to determine:
1. A) The amount of enhancement at the tumor site and in benign breast tissue at 10 
minutes and 20 minutes after contrast injection. B) The difference between tumor and 
benign breast tissue enhancement at 10 minutes and 20 minutes after contrast 
injection. (This is quantitative data that underlies the Radiologists’ clinical judgement 
and allows them to segment the tumors.) 
2. The time needed to acquire the supine MRI images.

D17168
Version  05.07.19
11
3. The percentage of cases that can be successfully segmented by both Radiologists 
using the prone MRI images, in conjunction with mammogram and US images. (If a 
tumor cannot be segmented based on the supine MRI images, there are many possible 
causes. One of these causes is that the tumors intrinsically do not enhance with 
gadolinium contrast, even at the optimal time (10 minutes after contrast injection). 
Based on previous experience, we expect that less than 10% of neoplasms will not 
enhance at 10 minutes and will not be able to be segmented. Knowing this exact 
percentage in this study will help us understand how frequently this may contribute to a 
potential inability to segment tumors at 20 minutes.)
4. If overall patient comfort drastically changes in prone vs. supine MR breast imaging. 
Clinical MRI breast imaging is obtained with patients lying in the prone position (on their 
belly).  This position has the potential to cause difficulty breathing, pain along the rib-
cage, and increased claustrophobia (face down). By asking each participant to rate both 
positions using a scale form 0-5, we can assess their overall comfort, and help 
determine if supine MR breast imaging is indeed the preferred position for our 
participants.
These secondary data will be tabulated and summarized using descriptive statistics.
Approximately 300 patients are diagnosed with breast cancer and 100 are diagnosed with 
DCIS annually at DH. Diagnostic prone MRI is clinically indicated in 75% of these patients. 
Therefore, approximately 300 diagnostic prone MRIs are performed annually at DH.  Assuming 
that 25% of these patients will not meet the eligibility requirements, 225 patients would be 
eligible annually. Assuming that half of the eligible patients will be accrued, we should 
complete accrual of 62 patients in 6 months.
Relevant data will be saved in Velos electronic case report forms.
Section 8.  SAFETY AND DATA MONITORING
This study will be monitored by the Data Safety Monitoring and Accrual Committee 
(DSMAC) of the Norris Cotton Cancer Center.  The Committee meets quarterly to review 
accrual rates and information for studies that have accrued participants.  The Clinical Cancer 

D17168
Version  05.07.19
12
Review Committee (CCRC) determines the frequency of DSMAC review. The DSMAC has the 
authority to suspend or to recommend termination to the CCRC of all research activities that 
fall within its jurisdiction.  In the event that a study is suspended or terminated, that information 
will be forwarded to the CPHS (Dartmouth IRB) office.
Section 9.  PROTOCOL COMPLIANCE MONITORING
Clinical research monitoring for regulatory compliance and data integrity will be conducted 
according to the NCI-approved NCCC Data and Safety Monitoring Plan.  Monitoring is 
conducted by appropriately trained staff of the NCCC Office of Clinical Research and 
Dartmouth-Hitchcock Medical Center's Clinical Trials Office (CTO) who are not involved in the 
study.  This monitoring will include periodic assessment of the regulatory compliance, data 
quality, and study integrity.  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g., diagnostic laboratory).  Study records will be reviewed 
and directly compared to source documents and the conduct of the study will be discussed 
with the investigator.  Monitors may request access to all regulatory documents, source 
documents, CRFs, and other study documentation for on-site inspection.  Direct access to 
these documents is guaranteed by the investigator, who must provide support at all times for 
these activities.
Data will be monitored for timeliness of submission, completeness, and adherence to 
protocol requirements.  Monitoring will begin at the time of participant registration and will 
continue during protocol performance and completion. 
Section 10.  DATA TRANSFER
De-identified study data will be shared with the funding organization, CairnSurgical, Inc. 
(Cairn), under a data use agreement. Cairn will use the data to inform commercial 
development of optimal imaging strategies and requirements for the creation of the BCL 
device.  In addition, the supine MRI data set will also help Cairn to develop efficient image 
processing techniques and algorithms to extract anatomical and disease features required for 
the construction of the BCL device. Published results from this study and other findings derived 

D17168
Version  05.07.19
13
from the study data may be submitted to the FDA to support regulatory submission(s) for the 
BCL device.
Cairn will store and maintain the data indefinitely in a secure password-protected database.
Data from participants who signed a consent which does not name CairnSurgical, Inc. in 
the privacy section will not be shared with Cairn.
Section 11.  RECORD RETENTION
Following closure of the study, the investigator will maintain all site study records in a safe 
and secure location.  The records are maintained to allow easy and timely retrieval when 
needed (e.g., for audit or inspection) and, whenever feasible, to allow any subsequent review 
of data in conjunction with assessment of the facility, supporting systems, and staff.  Upon 
completion of study analysis, research information is stored in Dartmouth College Records 
Management off-site storage located at 6218 Etna Road, Hanover, NH.  Documents are 
shredded on-site after 50 years of storage.
Electronic case report forms, participant, and study information will be kept in the 
password-protected Velos Clinical Trials Management System (or equivalent) indefinitely.
Section 12.  HUMAN SUBJECTS
All patients will sign an informed consent, which describes the treatment to be performed 
and discusses the risks and benefits of participation in the study.
Patients must give a statement of informed consent.  The informed consent must meet the 
requirements of the FDA (21 CFR 50.25 Elements of Informed Consent) and the Committee 
for the Protection of Human Subjects at Dartmouth College, the Dartmouth-Hitchcock Medical 
Center’s IRB. The team members obtaining consent will have the appropriate education, 
expertise, and background to understand and relay the concepts in the study and answer 
questions.  They will have documented protocol-specific training.   Each subject must sign and 
date an informed consent prior to the subject entering the study (i.e., before initiation of non-
routine tests).  This form must be counter-signed by the person who conducted the consent 
discussion.  The final consent form must be agreed to by the institution’s IRB (CPHS) and 
must contain all elements required by federal regulation in language readily understandable by 

D17168
Version  05.07.19
14
subjects.  Each subject’s original consent form will be retained by the investigator.  A copy of 
the informed consent will be given to the subject.
Risk/Benefit analysis: 
Risks associated with this study include the risks additional time in the MRI machine and 
potential confidentiality risks.
The risk of additional time in the MRI machine is negligible. 
Risk of breach of confidentiality of the medical records of participants will be minimized.  
Subject identity is numerically coded and is not available to research investigators or otherwise 
stored on the databases maintained by the researchers to archive the clinical encounters 
accrued as part of the studies conducted under this protocol.  In this regard, all conventional 
clinical image data is de-identified prior to its use for analysis.  Databases which are used to 
store subject-sensitive information, even though completely de-identified as stored, are 
password-protected and encrypted during file/data transfers from viewing terminals.  As further 
safe-guard, the Data Safety Monitoring and Accrual Committee of the Norris Cotton Cancer 
Center will oversee the conduct of the trial.
The importance of the knowledge to be gained and the ultimate potential for benefit for 
future patients if this new technology is effective far outweighs the nominal risks experienced 
by the women who participate in this clinical study.
Pregnant women will be excluded due to the potential risk of gadolinium to the fetus. 
Women with child-bearing potential are eligible for enrollment into the study.  The risks of 
participating in the imaging sessions for these women are no greater than for any other 
participant.  Risks associated with breast surgery vis-à-vis child-bearing potential are outlined 
as part of standard of care.  Thus, any woman of child-bearing years enrolled in this protocol 
would already understand (and have accepted) the surgical risks to her fertility. 
Only women will be enrolled in the study because breast cancer is predominantly a female 
disease.  The imaging apparatus is design to accommodate the size and shape variations 
associated with the adult female breast.  While a very small proportion of breast cancer 
appears in males, the imaging systems are not designed to image the male breast.  All racial 
and ethnic categories will be recruited commensurate with the racial/ethnic composition of the 
DHMC patient catchment area.

D17168
Version  05.07.19
15
Patients will be considered “on study” and will be monitored for adverse events by the 
Principle Investigator from the time of registration until 2 weeks after imaging. 
Section 13.  OBLIGATIONS OF INVESTIGATORS
The Principal Investigator is responsible for the conduct of the clinical trial at the site in 
accordance with Title 21 of the Code of Federal Regulations and/or the Declaration of Helsinki. 
The Principal Investigator is responsible for personally overseeing the treatment of all study 
patients. The Principal Investigator must assure that all study site personnel, including sub-
investigators and other study staff members, adhere to the study protocol and all 
FDA/GCP/NCI regulations and guidelines regarding clinical trials both during and after study 
completion.
The Principal Investigator will be responsible for assuring that all the required data will be 
collected and entered onto the Case Report Forms. Periodically, monitoring visits will be 
conducted and the Principal Investigator will provide access to his original records to permit 
verification of proper entry of data. At the completion of the study, all case report forms will be 
reviewed by the Principal Investigator and will require his final signature to verify the accuracy 
of the data.
Section 14.  REFERENCES
1. Barth R, Krishnaswamy V, Paulsen K, Rooney T, Wells W, Rizzo E, Angeles C, Marotti 
J, Zuurbier R, Black C.  A patient specific 3D printed form accurately transfers supine 
MRI-derived tumor localization information to guide breast conserving surgery. Ann 
Surg Onc 2017; 10:2950-56.
2. Leong C, Daniel B, Herfkens R, et al.  Characterization of breast lesion morphology with 
delayed 3DSSMT: an adjunct to dynamic breast MRI. JMRI 2000; 11:87-96.