1

Research Organization Document

Kyle Garafolo
Stephanie Hufnal
Keenan Fuller

Section 1
Problem that needs to be solved: The problem is there are no current studies indicating the
efficacy of EZFluence software with the planning of prone breasts. This study aims to identify
the effectiveness of EZFluence software by evaluating several core metrics.

Key questions that need to be answered:

1. Will the use of EZFluence improve planning time in breast cancer patients being treated
in the prone position?
2. What impact will the use of the EZFluence software have on the overall dose uniformity
of the plan?
3. How will the use of EZFluence impact the global maximum dose of the final plan?
4. Will there be a noticeable effect on dose to the OAR in plans generated with the software
compared to the plans generated without?
5. What is the clinical potential for software such as EZFluence?

Evidence of gap in literature: To date, only one peer reviewed source has examined the
benefits of EZFluence as compared to manual FiF techniques for the planning of supine breast
patients. The results of this study found that EZFluence was able to greatly improve treatment
planning time, reduce the volume of PTV receiving 105% of the prescribed dose, and achieved
similar dose constraints to the OAR. The purpose of this proposed case study will be to evaluate
the EZFluence software as it relates to the planning of prone breast patients.

References to support research:

1. Haffty, BG. Supine or prone breast radiation: Upsides and downsides. Int J Radiat Oncol
Biol Phys. 2018;101(3):510-512. https://doi.org/10.1016/j.ijrobp.2018.03.023.
2. Keenan LG, Lavan N, Dunne M, McArdle O. Modifiable risk factors for acute skin toxicity
in adjuvant breast radiotherapy: Dosimetric analysis and review of the literature. Med
Dosim.2019; 44(1):51-55. https://doi.org/10.1016/j.meddos.2018.01.004.
3. Yoder T, Hsia AT, Xu Z, Stessin A, Ryu S. Usefulness of EZFluence software for
radiotherapy planning of breast cancer treatment. Med Dosim. 2019.
https://doi.org/10.1016/j.meddos.2018.12.001.
4. Olson KN. Improving treatment outcomes of breast radiation therapy: the prone position.
Radiat Therapist. 2014; 23(1):21-26. https://web-b-ebscohost-
com.libweb.uwlax.edu/ehost/pdfviewer/pdfviewer?vid=7&sid=6c25b527-3254-4499-9769-
da885b9aa3d5%40sessionmgr102. Published Spring 2014. Accessed May 31, 2019.
 2

***Note - I could not find a doi for this article after extensive searching
5. Venkatesan K, Deshpande S, Anand V, et al. Comparison of heart and lung doses in deep
inspiration breath hold radiation therapy and prone position radiation therapy for whole
breast radiation therapy. Int J Radiat Oncol Biol Phys. 2018; 102(3):489-490.
https://doi.org/10.1016/j.ijrobp.2018.07.1393
6. Mak KS, Chen YH, Catalano PJ, et al. Dosimetric inhomogeneity predicts for long-term
breast pain after breast-conserving therapy. Int J Radiat Oncol Biol Phys. 2014; 93(5):1087-
1095. https://doi.org/10.1016/j.ijrobp.2014.05.021
7. Hymas, R.V. ; Jawad, M.S ; Mangona, V.S. ; et al. Dosimetric predictors of toxicity and
cosmesis in women treated with hypofractionated whole-breast irradiation. Int. J. Radiat.
Oncol. Biol. Phys. 2014;90(1):S270–s271.https://doi.org/10.1016/j.ijrobp.2014.05.930

Finalized research topic title:

Radiation therapy treatment of the prone breast using EZFluence: A case study

Section 2
Basic Study Components
1. IRB approval: The group members needing IRB approval for this research study are
Kyle and Stephanie. Kyle has been in contact with his preceptor and has started the
process to gain approval. Dr. Nasiruddin Mohammed, MD of Northwestern Medicine
will be serving as the principal investigator for the group

2. Prospective or Retrospective? This research project will be considered a prospective

case study in that the plan will be to collect and evaluate studies using the techniques
provided through the EZFluence software. This technique has not been studied for its use
in prone breast cases, which means the data will be new at the time the research is
conceived.

3. Number of patients for data collection: The number of patients in the dataset for this
project will be approximately 10.

4. Type of study: A comparison of planning techniques, comparing dose to OAR, as well

as an assessment of prescription dose coverage to the breast tissue.
 3

5. Roles of each group member:

Group Leader – Kyle will be the group leader
Data Collector(s) – Stephanie and Kyle
Data analysis – Stephanie, Kyle, and Keenan
Writer – Keenan
Editor – Stephanie and Kyle

Data Collection Details

1. Number of clinical sites: 2 clinical sites will be used for data collection:
- Northwestern Medicine Delnor Cancer Center – 304 Randall Rd, Geneva, IL 60134
- Northwestern Medicine Warrenville Cancer Center – 4405 Weaver Pkwy,
Warrenville, IL 60555

2. Information of interest: Evaluation will include the total amount of time it takes to plan
a prone breast treatment using traditional field-in-field (FiF) techniques compared to the
total time taken to plan a similar treatment using the EZFluence software. Dose
uniformity to the target will also be taken into consideration and differences/similarities
between the two plans will be discussed. As far as structures that will be evaluated, we
will be making sure that the tumor volume has 95% prescription dose coverage and
noting the total dose to the normal breast tissue. Data collected will also include the total
volume of the PTV and breast, as well as dose the maximum, mean, and relevant dose to
the critical structures such as the heart and lung. The overall global maximum dose or
hotspot will be accounted for with both treatment technique types.

3. Inclusion criteria and exclusion criteria: Treatment plans from approximately 10

patients from two separate facilities will be evaluated. Patients will be limited to those
with intact, pendulous breasts (following lumpectomy) without nodal involvement, and
set up in the prone position as selected by the attending radiation oncologist. Patients
included in this study will be receive hypofractionated whole breast irradiation with a
prescription dose of 266 cGy in 16 fractions to a total dose of 4256 cGy. Planning
techniques will include non-divergent medial and lateral 3D-CRT tangential beams
produced by manual FiF techniques and EZFluence software. Dose from any boost after
the initial 4256 cGy will not be included in this study.

4. Study variables: To eliminate any discrepancies in treatment plans, Kyle and Stephanie
will be handling all the planning and data collection since both their clinical sites are run
by Northwestern Medicine and follow the same protocols and treatment parameters. Each
1 of the roughly 10 patients will be planned by Kyle or Stephanie, meaning that if one
planner completes the treatment for the manual FiF technique than that person will also
 4

complete the plan utilizing the EZFluence software. Stephanie will be doing all the
contouring for each patient so that there is consistency in patient contours. All patient
datasets will be pulled from the Warrenville site and planned for that site to have
uniformity in both patient CT simulation and treatment machine factors/variables. For all
plan studies in this case study, a beam energy of 6x will be used instead of any mixed
beam configurations.

5. Statistical analysis: The main parameters we will be analyzing will be the total planning
time ratio between plans done with and without the use of EZFluence software as well as
the percent difference. The dose difference between the plans will also be reviewed
which will include total dose to the tumor volume, breast tissue, and mean doses to the
heart and lung. Since this is mainly a comparison study with limited variables, a more
complex statistical analysis will most likely not be necessary.

6. Housing of data: All research and data will be housed in the group OneDrive folder for
ease of use. Excel spreadsheets will be used to track patient and treatment plan
parameters and variables.

7. Anonymizing patients: All patients in the study will be assigned a number and patient
identifiers will be removed before sharing secured data between group members so that
we will be in line with HIPAA protocols. A master list for the patient identities will be
kept on a secured server at the Northwestern Medicine campus.

8. Available resources: In addition to literature search and review, we have resources

which include staff dosimetrists, physicists, and physicians to aid in any treatment related
questions. We also have physical media in the form of textbooks and scholarly journals
for any additional research required.

9. Previous research studies: Since there is no current research study for the use of
EZFluence in prone breast radiation treatment planning, we will not be able to draw
much for data analysis. However, we can compare results from our study with that of the
study done by Yoder, et al listed in our references which demonstrates the usefulness of
the EZFluence software in supine breast treatments. We will be using dose constraints
from the RTOG studies for comparison of our treatment outcomes to normal tissue
tolerances.
 5

10. Loose weekly deadlines:

▪ Outline Section I: June 11

▪ Outline Section II: June 18

▪ Outline Section III: June 25

▪ Outline Section IV: July 2

▪ Capstone Paper Rough Draft I: July 10

▪ Capstone Paper Rough Draft II: August 1

This document will serve as our research organizer and research guide. We will refer to it often
so that we stay on track with project development. This document may change as our study
progresses.