3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery: Does 3D Improve Patient Reported Outcomes in Primary Breast Augmentation?
Phase: NA
Conditions: Hypomastia, Primary Breast Augmentation
Sponsor: Washington University School of Medicine

Version 3; 8/27/14 
 
page 1 of 12 
 
 
 
 
 
 
 
3D BREAST IMAGING FOR COSMETIC AND RECONSTRUCTIVE BREAST 
SURGERY: DOES 3D IMAGING IMPROVE PATIENT REPORTED OUTCOMES IN 
PRIMARY BREAST AUGMENTATION? 
 
 
Washington University School of Medicine 
Department of Surgery 
660 S. Euclid Ave., Campus Box 8109 
St. Louis, MO 63110 
 
Version date: 8/27/14 
 
 
 
 
 
Principal Investigator:  
Terence Myckatyn, M.D. 
 
Phone:  
 
 
(314) 996-3255 
Email:   
 
 
myckatynt@wudosis.wustl.edu 
 
 
Sub-Investigators: 
 
Marissa Tenenbaum, MD 
 
 
 

Version 3; 8/27/14 
 
page 2 of 12 
3D BREAST IMAGING FOR COSMETIC AND RECONSTRUCTIVE BREAST 
SURGERY: DOES 3D IMAGING IMPROVE PATIENT REPORTED OUTCOMES IN 
PRIMARY BREAST AUGMENTATION? 
 
 
TREATMENT SCHEMA 
 
 
Eligible Patients 
Patients age 18 years or older 
Patients scheduled for a breast augmentation procedure 
Provided informed consent 
Enrollment 
Randomization 
Control Group: Standard Preoperative Evaluation 
or 
Intervention Group: 3D Image Simulation + Standard Preoperative Evaluation 
or 
 Non-Randomized Cohort: 3D Image Simulation + Standard Preoperative Evaluation 
Intervention 
Breast Augmentation Surgery 
Post-Intervention Monitoring 
Standard post-operative recovery 
Follow-up 
Routine clinic visit 6 months postop 
2D and 3D photography repeated 
Breast Q repeated 
Baseline 
Breast Q administered 
2D and 3D photography 

Version 3; 8/27/14 
 
page 3 of 12 
 
 
TREATMENT SCHEMA .................................................................................................................................... 2 
1.0 
BACKGROUND AND RATIONALE ........................................................................................................ 4 
2.0 
OBJECTIVES ........................................................................................................................................ 5 
3.0 
PATIENT SELECTION ........................................................................................................................... 5 
4.0 
TREATMENT PLAN .............................................................................................................................. 5 
5.0 
ADVERSE EVENT REPORTING ............................................................................................................. 7 
6.0 
DATA AND SAFETY MONITORING ...................................................................................................... 7 
7.0 
STATISTICAL CONSIDERATIONS .......................................................................................................... 8 
8.0 
REFERENCES ..................................................................................................................................... 10 
APPENDIX A:  STUDY TIMELINE.................................................................................................................... 11 
APPENDIX B:  STUDY VISIT SCHEDULE ......................................................................................................... 12 
 
 
 

Version 3; 8/27/14 
 
page 4 of 12 
 
1.0 
BACKGROUND AND RATIONALE 
 
Advances in 3D breast imaging. Three-dimensional imaging, extensively utilized to provide 
objective outcome measures in craniofacial surgery, has been adapted for evaluation of the 
breast. Three-dimensional images of the breast can be used to facilitate patient education, 
surgical planning, as well as both a research and marketing tool by plastic surgeons. Over the 
past few years, investigators have identified breast measurements calculated from computerized 
renderings of three-dimensional photographs and documented changes in these measurements 
following surgical procedures such as breast reduction, breast reconstruction with implants, and 
breast augmentation. Changes in these parameters after operative intervention have enabled 
surgeon scientists to compile objective quantitative breast data, or “mammometrics” (1). 
Mammometric data can be statistically analyzed, longitudinally evaluated in the same patient over 
time, and correlated with other quantitative data including patient reported outcomes. Some of the 
useful mammometric measurements that can be used to quantify and compare pre- with 
postoperative breast surgery include total and split breast volumes, distances from the low breast 
crease to the nipple, and projection of the breast and nipple from the chest wall among others.  
 
Outcomes research in plastic and reconstructive surgery is more likely to focus on patient 
reported outcomes than survival. While the plastic surgery literature is replete with surveys 
focused on judging patient satisfaction, they are infrequently validated or comprehensive. The 
Breast Q has been established as a validated instrument to provide a quantitative measure of the 
unique features of patient reported outcomes following breast surgery. This instrument represents 
the most comprehensive and specific quantitative method for patient self-assessment following 
breast surgery. Recently, McCarthy and colleagues published, for the first time, patient 
satisfaction in 41 patients who underwent breast augmentation and were evaluated with the 
Breast Q. This study found statistically significant improvements following breast augmentation in 
the “satisfaction with breasts” – 14 item scale, “psychological well-being” – 9 item scale, and 
“sexual well-being” – 5 item scale. This study does not, however, include information on either the 
benefits of 3D imaging or the mammometric parameters most closely associated with improved 
satisfaction. Interestingly, the core scale “satisfaction with care” was not evaluated in this study. 
While this particular core scale may not have been relevant to a study looking at the overall 
benefits of breast augmentation, we suspect that it may be highly relevant to the aesthetic 
surgery patient where the consultation experience is more likely to impact overall patient 
satisfaction. 
 
This study will evaluate the impact of incorporating 3D imaging during preoperative consultation 
on patient reported outcomes in primary breast augmentation surgery. 3D imaging can be used to 
facilitate patient education and surgical planning in the context of breast augmentation. The 
purpose of this study is to utilize the most objective assessment available for assessing patient 
satisfaction with breast augmentation - the Breast Q - in a prospective randomized trial. We will 
evaluate whether 3D imaging used in consultation 1) can improve patient reported outcomes, and 
2) whether there are measurable mammometric parameters that are associated with improved 
patient satisfaction and 3) if utilizing 3D imaging in the pre-operative consultation significantly 
influences final mammometric parameters compared to patients receiving a traditional 
consultation that does not involve 3D breast surgical simulation.  
 
It is hoped that patients of surgeons that utilize this technology in the preoperative consultation 
will have significantly higher Breast Q breast augmentation module scores 6 months after 
surgery. “Satisfaction with care” - one of six core scales within the Breast Q - will be particularly 
impacted by using 3D image simulation in the consultation experience. Additionally, it is thought 
that superomedial pole fullness and central nipple position as quantified with mammometrics that 

Version 3; 8/27/14 
 
page 5 of 12 
the 3D imaging can provide will be associated with higher Breast Q scores, especially the 
“satisfaction with breasts” items.  
 
This study will represent one of the first randomized control trials performed to address patient 
satisfaction with breast augmentation.  
 
2.0 
OBJECTIVES 
 
2.1 
Primary Objective 
To establish whether 3D imaging used in breast augmentation consultation can improve 
patient reported outcomes.   
2.2 
Secondary Objective 
To determine if measureable mammometric parameters are associated with improved 
patient satisfaction. 
 
3.0 
PATIENT SELECTION 
 
3.1 
Inclusion Criteria 
- 
18 years of age or older 
- 
Scheduled for elective breast augmentation cosmetic procedure 
3.2 
Exclusion Criteria 
- 
Cognitively unable to provide informed consent 
- 
Breast reconstruction for malignancy 
3.3 
Inclusion of Women and Minorities 
 
Due to the nature of the surgical procedure, men are excluded from participation in this study.  
Members of all races and ethnic groups are eligible for this trial. 
 
3.4 
Inclusion of Non-Randomized Cohort 
Patients who refuse the option of randomization but otherwise meet the inclusion and 
exclusion criteria will be offered participation in this study as part of a non-randomized 
cohort.  All aspects of the study as described in the protocol will be followed with exception 
of the randomization will be followed.   
 
 
 
4.0 
TREATMENT PLAN 
 

Version 3; 8/27/14 
 
page 6 of 12 
4.1 
Preoperative Evaluation 
Standard preoperative evaluation will be conducted on all patients.  It is routine practice in 
cosmetic surgery to take baseline pictures and measurements.  Both 2D and 3D photography will 
be performed on all patients.  
 
4.2 
Randomization 
 
100 patients will be recruited in the randomized cohort.  Randomization will be performed by 
a Research Patient Coordinator and the patient assigned to the control group or the 
intervention group.  Randomization will only occur after the patient has signed the informed 
consent and will be documented in the case report file as well as communicated to the 
treating surgeon.  
 
Intervention group 
In the intervention group, in addition to standard preoperative evaluation, 3D image 
simulation will be performed.   
 
Control group 
In the conventional group, only the standard preoperative evaluation will be performed.   
 
Non-Randomized cohort 
In the non-randomized cohort, the patient can choose to have the standard evaluation 
with the addition of the 3D image simulation or not based on discussion with their 
surgeon.   
 
Minimizing measurement bias 
Blinding of the patient or surgeon will not be possible due to the need for the 3D imaging 
simulation to be openly discussed and viewed prior to the operation for patients randomized 
to 3D intervention and for the nonrandomized cohort.   
 
All subjects will be administered the Breast Q questionnaire prior to surgery regardless of 
assigned group.  The questionnaire will take approximately 5-10 minutes of time to complete.  
 
4.3 
Operative Procedure 
 
The elective surgical procedure will be conducted as planned.   
 
 
4.4 
Postoperative Care 
 
The postoperative management is standard of care for all patients who undergo breast 
augmentation procedure and will not be altered by their participation in this study.  
 
4.5 
Duration of Follow-Up 
 
Patients will be followed for 6 months following their surgical procedure.   Postoperative 
complications and adverse events will be closely monitored.  Patients will be followed until resolution 
or stabilization of the adverse event. 
 

Version 3; 8/27/14 
 
page 7 of 12 
At the 6 month follow-up appointment, routine postoperative 2D and 3D images will be taken for 
comparison to baseline.  As part of this research study, the Breast Q questionnaire will be re-
administered to the subject.   
 
 
4.6 
Criteria for Removal from Study 
 
If at any time the constraints of this protocol are considered to be detrimental to the patient’s 
health and/or the patient no longer wishes to proceed with the protocol intervention, the patient 
should be removed from the study and the reason(s) for discontinuation documented in the case 
report forms. 
 
Otherwise, the patient will receive the intervention and be followed as described. 
 
 
5.0 
ADVERSE EVENT REPORTING 
 
5.1 
Adverse Events 
 
Definition: any unfavorable medical occurrence in a human subject including any 
abnormal sign, symptom, or disease. 
 
Attribution (relatedness), Expectedness, and Seriousness: the definitions for the 
terms listed that should be used are those provided by the Department of Health and 
Human Services’ Office for Human Research Protections (OHRP).  A copy of this 
guidance 
can 
be 
found 
on 
OHRP’s 
website: 
http://www.hhs.gov/ohrp/policy/advevntguid.html 
 
5.2 
Reporting to the Human Research Protection Office (HRPO) at Washington 
University: 
 
All HRPO guidelines for reporting unanticipated problems will be followed. 
 
 
6.0 
DATA AND SAFETY MONITORING 
 
The study principal investigator and Research Patient Coordinator will closely monitor for adverse events 
on an ongoing basis. Once the principal investigator or Research Patient Coordinator becomes aware of a 
research related adverse event, the AE will be reported to the HRPO according to institutional guidelines. 
 
6.1 
Potential risks 
A possible breach of confidentiality of study data is an unlikely risk. 
 
6.2 
Minimization of risks 
 
PHI will be collected and include the patient’s name, date of birth, date of surgery and 
date of follow-up. The patient’s name and other identifiers will be kept in a password-
protected database in which access will be granted to only the research team. 

Version 3; 8/27/14 
 
page 8 of 12 
Participants will be assigned a study number and after the data is collected, all identifiers 
with the exception of date of birth will be removed. 
 
 
All study papers with and without identifiable study information will be kept in a locked file 
cabinet in a locked room in a locked office for the duration of the study data collection 
period. All information will be entered into a database. The database is secure, saved on 
a firewall protected network, and password protected. All hard copies of identifiable 
information will be disposed of by shredding after the information is reviewed and locked 
into the database, the analysis has been made, and the report has been written, and one 
year has passed from the date of publication. 
 
6.3   
Potential benefits 
 
Direct benefit to the patient is unknown.  The patients randomized to receive the 3D 
simulation of what their implants are anticipated to look like may feel greater satisfaction 
with the aesthetic results after their surgery.   
 
7.0 
STATISTICAL CONSIDERATIONS 
 
7.1 
Study Endpoints 
 
Primary endpoint 
BREAST Q Augmentation Module. This includes 6 core items, each with several sub-items. Of 
the 6 core items, 3 are recently shown to statistically significantly improve in patients undergoing 
breast augmentation: 1) satisfaction with breasts 2) psychological well-being 3) sexual well being. 
A fourth, 4) satisfaction with care, however, may be particularly relevant to the discerning 
aesthetic surgery patient using 3D imaging in consultation. The other core items in this instrument 
are 5) physical well-being and 6) satisfaction with overall outcome which will also be recorded.  
 
Secondary endpoints 
All patients will undergo standard 2D as well as 3D imaging before and after surgery. During 
consultation, and in the postoperative period, reviewing 3D imaging and morphing software will be 
unique to the experimental group. 3D imaging from all patients will be used to obtain 
mammometric data. Pre- , and post- op mammometric data (volumes, vectors, surface distances, 
anatomic landmarks), as well as the measurable change in these parameters before and after 
surgery will be correlated with changes in Breast Q patient reported outcomes scores.  This will 
enable us to identify particular mammometric parameters that are a) associated with improved 
patient reported outcomes and b) determine whether certain mammometric parameters are 
significantly different in patients who had 3D image simulation as part of their preoperative 
consultation relative to those that did not. 
 
 
7.2 
Study Design 
 
To achieve comparable groups for known and unknown risk factors randomization will be 
performed as unistratified block randomization with random block sizes in a 1:1 allocation ratio.  
Allocation to treatment will be carried out by means of a computer-generated random study 
numbers with group assignment.   
 
 

Version 3; 8/27/14 
 
page 9 of 12 
Non-randomized cohort 
Patients who choose not to be randomized but otherwise meet the inclusion and exclusion 
criteria will be offered participation in this study as part of a non-randomized cohort. Their 
data will still be analyzed for the purpose of addressing the secondary objective.   
 
 
7.3 
Sample Size 
 
Appropriate sample size is calculated based on assumption of difference of 20 percent in patient 
satisfaction as compared with the control group.  This difference is considered clinically relevant 
baed on previous similar studies.  A sample size of 100 patients (50 in each group) is considered 
sufficient to prove this difference, if present (alpha error set at 0.05, power>99 percent).   
 
Approximately 75 patients per year undergo a breast augmentation procedure at Washington 
University Medical Center.  The estimated time frame to randomize 100 patients is approximately 
24 months.  
 
Non-randomized cohort 
 
Up to 50 patients will be included in the non-randomized cohort.   
 
7.4 
Data Analysis 
 
Data analysis for this study will be descriptive in nature. Demographic and clinical characteristics 
of the sample, as well as post-surgery complications will be summarized using descriptive 
statistics and the confidence intervals will also be provided.  
  
Patients assigned to the intervention group (3D simulation) will be compared with those who had 
conventional techniques using х2 tests for categorical variables and Student’s t-tests for 
continuous variables. For the t-tests equal variances were not be assumed, unless significant by 
Levene’s test. Mann-Whitney U tests will be utilized for non-normally distributed variables.  Two-
tailed P values 0.05 will be considered statistically significant. 
 
Multivariate analyses for Breast Q scores, mammometric parameters, and patient satisfaction will 
be performed using binary logistic regression and linear regression models to examine the 
relationship between intervention groups and examined outcomes and to identify potential 
confounders. The results of multivariate analyses will be expressed as odds ratios with 
corresponding 95% confidence intervals. All analyses will be performed using SPSS 20.0 
statistical software (SPSS Inc. Chicago, IL). 
 
 

Version 3; 8/27/14 
 
page 10 of 12 
 
8.0 
REFERENCES 
 
1 
Tepper, O. M. et al. Mammometrics: the standardization of aesthetic and reconstructive breast 
surgery. Plastic and Reconstructive Surgery 125, 393-400  (2010). 
2 
Tepper, O. M., Small, K., Rudolph, L., Choi, M. & Karp, N. Virtual 3-dimensional modeling as a 
valuable adjunct to aesthetic and reconstructive breast surgery. American journal of surgery 
192, 548-551 (2006). 
3 
Tepper, O. M. et al. 3D analysis of breast augmentation defines operative changes and their 
relationship to implant dimensions. Annals of Plastic Surgery 62, 570-575 (2009). 
4 
Quan, M. et al. Defining pseudoptosis (bottoming out) 3 years after short-scar medial pedicle 
breast reduction. Aesthetic plastic surgery 35, 357-364, (2011). 
5 
Small, K. H. et al. Re-defining pseudoptosis from a 3D perspective after short scar-medial pedicle 
reduction mammaplasty. Journal of plastic, reconstructive & aesthetic surgery : JPRAS 63, 346-
353 (2010). 
6 
Tepper, O. M. et al. Three-dimensional imaging provides valuable clinical data to aid in unilateral 
tissue expander-implant breast reconstruction. The breast journal 14, 543-550, (2008). 
7 
Karanicolas, P. J. et al. Measurement and interpretation of patient-reported outcomes in 
surgery: an opportunity for improvement. J Gastrointest Surg 15, 682-689 (2011). 
8 
Pusic, A. L. et al. Measuring patient outcomes in breast augmentation: introducing the BREAST-
Q Augmentation module. Clinics in Plastic Surgery 36, 23-32 (2009). 
9 
Pusic, A. L. et al. Development of a new patient-reported outcome measure for breast surgery: 
the BREAST-Q. Plastic and Reconstructive Surgery 124, 345-353 (2009). 
 
 
 
 

Version 3; 8/27/14 
 
page 11 of 12 
APPENDIX A:  STUDY TIMELINE 
 
 

Version 3; 8/27/14 
 
page 12 of 12 
APPENDIX B:  STUDY VISIT SCHEDULE 
 
 
Screening2 
Intervention 
6 Months Post-Op4 
Standard Pre-operative Evaluation1 
X 
 
 
Informed consent 
X 
 
 
Breast Q Questionnaire 
X 
 
X 
Randomization 
 
X 
 
2D and 3D Photography 
X 
 
X 
3D Simulation 
 
X3 
 
Peri and postoperative complications 
 
 
X 
1 Study-relevant past medical and surgical history to be documented from consult and pre-surgical evaluation 
2Screening procedures to be completed within 90 days of surgery 
3Only for subjects randomized to intervention group 
4To be performed 6 months from day of surgery ± 60 days.