Research Organization Document

Section 1
Problem that needs to be solved
The most commonly used collimator angles for tangent breast treatments could be yielding
more interleaf transmission than necessary when using an Elekta linear accelerator. In
order to meet dose constraints based on the Michigan Radiation Oncology Quality
Consortium (MROQC) protocol of 1.2 Gy mean dose to the heart on a left sided breast or 0.7
Gy on the right side, an additional collimator rotation could be used.

Key questions that need to be answered

What is the importance of minimizing heart, lung, and LAD dose?
What techniques are commonly used to minimize heart, lung, and LAD dose?
How are Elekta MLCs designed?
How can interleaf transmission affect a plan?
What planning techniques are used currently?
How does our planning technique minimize dose?

Evidence of gap in literature

The goal of any radiation therapy treatment plan is to provide adequate coverage to the
tumor volume while sparing surrounding tissue and critical structures. In breast
treatments dose to the heart can cause ischemic heart disease and radiation pneumonitis.
According to Darby et al,1 for every gray the mean heart dose receives, the chance for heart
disease or major coronary events increases by 7.4%. In another study, Taylor et al 2 states
that there is no threshold dose to the heart below which no risk for ischemic heart disease
occurs. With respect to coronary artery disease, left‐sided breast patients have a 51%
higher rate of cardiac stress test abnormalities compared to patients with right‐sided
breast cancer, and 70% of those abnormalities occurred in the left anterior descending
coronary artery, with stenosis rates at the mid and distal left anterior descending artery
(LAD) significantly increased.3 Due to these risks of complications, techniques to reduce
dose to these organs are advantageous to the patient. There are many techniques to reduce
dose to critical structures for breast treatments, such as intensity-modulated radiation
therapy (IMRT), prone breast radiotherapy, deep-inspiratory breath hold and proton beam
therapy.2 Studies have been done to determine if interleaf leakage effects dose to critical
structures in various treatment plans. A study of interleaf leakage in an Elekta Synergy
machine shows that there is an average interleaf leakage of 1.9%. 4 The collimation design
of an Elekta linear accelerator is that of a single set of diaphragms that move perpendicular
to the multileaf collimator (MLC).5 Chen et al6compared doses to critical structures in IMRT
lung cases with various MLC transmission values. The lowest transmission value showed a
decrease in volume receiving 5 Gy (V5), V20, V10, and mean dose to the lung which could
reduce the chances for radiation pneumonitis. In a study by Chapek et al, 7 dose to the rectal
wall in prostate treatment plans was shown to decrease with an optimal collimator angle
meant to minimize transmission through MLC leaves. A similar study was done regarding
parotid gland irradiation and dose to the contralateral parotid gland and cochleae.
Although, no difference was shown in dose to these structures regardless of collimator
angle.8 As of now, no studies using an optimal collimator angle to reduce MLC leaf
transmission to limit dose to critical structures in a treatment for breast cancer has been
done. This study aims to determine if reducing leaf transmission with a collimator rotation,
in a standard 3D whole breast irradiation plan, will reduce the dose to critical structures
while maintaining adequate coverage of target volume.

References to support research

1. Darby SC, Ewertz M, McGale P, et al. Risk of ischemic heart disease in women after
radiotherapy for breast cancer. N Engl J Med. 2013;368(11):987-998.
https://doi.org/10.1056/NEJMoa1209825
2. Taylor CW, Kirby AM. Cardiac side-effects from breast cancer radiotherapy. Clinical
Oncol. 2015;27:621-629. https://dx.doi.org/10.1016/j.clon.2015.06.007
3. Welsh B, Chao M, Foroudi F. Reducing cardiac doses: a novel multi-leaf collimator
modification technique to reduce left anterior descending coronary artery dose in patients
with left-sided breast cancer. J Med Radiat Sci. 2016;64(2):114-119.
https://doi.org/10.1002/jmrs.191
 4. Vikraman S, Janardhan N, Kataria T, et al. Study of interleaf leakage and leaf
transmission in elekta synergy S beam modulator. Int J Radiat Oncol Biol Phys.
2010;78(3):S756-S757. https://doi.org/10.1016/j.ijrobp.2010.07.1751
5. Cosgrove V, Thomas M, Weston S, et al. Physical characterization of a new concept
design of an elekta radiation head with integrated 160-leaf multi-lead collimator. Int J
Radiat Oncol Biol Phys. 2009;75(3):S722. S723.
https://doi.org/10.1016/j/ijrobp.2009.07.1646
6. Chen J, Fu G, Li M, et al. Evaluation of MLC leaf transmission on IMRT treatment plan
quality of patients with advanced lung cancer. Med Dosim. 2018;43:313-318.
http://doi.org/10.1016/j.meddose.2017.10.008
7. Chapek J, Tobler M, Toy BJ, et al. Optimization of collimator parameters to reduce rectal
dose in intensity-modulated prostate treatment planning. Med Dosim. 2005;30(4):205-
212. https://doi.org/10.1016/j.meddos.2005.06.002
8. Sharma S, Manigandan D, Goyal S, et al. Influence of collimator rotation on dose
distribution and delivery in intensity modulated radiation therapy for parotid cancer. Int J
Cancer Ther Oncol. 2015;3:3212. http://dx.doi.org/10.14319/ijcto.32.12
9. Van Asselen B, Schwarz M, Vliet-Vroegindeweeij C, et al. Intensity-modulated
radiotherapy of breast cancer using direct aperture optimization. Radiother Oncol
2006;79:162-169. Https.//doi.org/10.1016/j.radonc.2006.04.010

Finalized Research Topic

Minimizing dose to the heart, left anterior descending artery, and lungs in whole breast
radiation by reducing interleaf transmission in Elekta linear accelerators.

Research approach
Section 2
The next section of your research organization document contains your research template
to follow as you begin your data collection. This section will change often but it will help
you to follow your goals closely as you progress.
Basic Study Components
1. Do any group members need to obtain IRB approval? (To determine if you need IRB
approval from your clinical site to conduct research, ask your clinical preceptor. The
preceptor should be aware of the protocol for your site or will be able to direct you
to the correct resource. If you DO need IRB approval you will most likely need to
prepare a formal research proposal and submit to the IRB.)
No
2. Will your study by prospective or retrospective?
Prospective
3. Number of patients for data collection
Minimum of 50 patients
4. Type of study (Ex: Comparison of planning techniques, comparison of OAR ect)
Comparison of planning techniques/OARs
5. Roles of each group member

Group Leader (someone who will keep the group on track, make sure group
members are adhering to deadlines, be the direct point of contact for the instructor
with overall questions, update the research organization document throughout the
course of research)
Madeline
Data Collector(s) (someone who will be doing the data collection and data
reporting in excel; maintaining journal entries)
Madeline and Makelle
Data analysis (someone who will be responsible for analyzing the raw data,
running any statistical tests and providing conclusive data for the writer)
Madeline, Makelle, and Shelby
Writer (someone who is responsible for writing the outline (later in the course) and
the paper; usually the best writer of the group takes this role)
Shelby
Editor (someone who is responsible for checking each draft for errors and
providing feedback and corrections to writer)
Makelle
 **The roles must be assigned in such a way that all of the work is divided equally. For
example, if 2 of 3 group members are data collectors, the 3 rd group member should be
the writer. Only 1 group member can write the paper so that the tone of paper is
consistent. Because the writing is such a large part of the research paper, the writer
should have a smaller part in the other aspects of the research paper.
Data Collection Details
1. How many clinical sites will you be collecting data from?
We will be collecting data from one clinical site.
2. What information are you interested in (if a planning study, list structures for
evaluation; if a study survey, list your study questions)?
We will be evaluating the maximum and mean heart doses, various lung doses,
and LAD dose.
3. What is your inclusion criteria? Exclusion criteria?
Our inclusion/exclusion criteria is patients receiving whole breast irradiation
wiht no nodal involvement. Each patient will be treated supine with or without
breath hold technique.
4. How will you limit the number of variables in your study? (For example, if you are
doing a planning study, only 1 person should be doing the planning to eliminate the
variables.)
To limit the number of variables, one of us will plan on the same Elekta machines
using Pinnacle treatment planning system (Version 14.0). All patients will have
the same positioning, fractionation, and planning criteria.
5. Read through Chapter 20 in your textbook. Are you interested in completing a
statistical analysis on this data? If so, what parameters will you be analyzing? (p-
value, mean, t-test ect.). (Keep in mind that anything beyond the test listed might be
required for your paper. The UWL stats center is an excellent resource for students
need a more complex statistical analysis. If you don’t know if you should do a more
in-depth analysis, reach out to the stats center and they will be able to provide you
with insight. It is also important to note that statistical analysis of any kind will add
robustness and validity to your research study!) Why do you think that those
metrics will be best for your topic?
Yes, we will be utilizing a t-test to analyze the values for mean and maximum
heart dose, mean and maximum LAD dose(left-sided patients), and mean, V20,
V10, and V5 lung dose,
6. Where will you house your data? (Excel ect., this will all be housed in OneDrive).
 We will house our data in Excel.
7. How will you anonymize your patients? (It is often necessary to transfer data sets or
patient information between group members. It is VERY IMPORTANT that you
respect HIPPA protocols! If you need to transfer data sets between facilities, we can
assist you through ProKnow. If you simply need to transfer data using a
spreadsheet, you must anonymize the patient information. It is up to you to decide
how to do this).
We shouldn’t need to transfer data sets between facilities. We will simply input
our data into a shared Excel spreadsheet giving each patient a number (1-50)
with no patient identifiers involved.
8. What resources (in addition to the literature search) are available for you to use?
Additional resources we can utilize are our clinical instructors, and the breast
radiation oncologist that is located at the clinical site where we will be doing the
planning.
9. Previous research study that will be used for data analysis (ex: RTOG study
constraints):
We will be following the MROQC study for our dose constraints, which will be
used for our data analysis.
10. List a loose weekly deadline for your data collection. (If you want to add writing
deadlines as well, feel free. However, paper due dates will be assigned in Research II
and Research III). It is very easy to be overwhelmed with this project, therefore, it is
ESSENTIAL that you set yourselves up for success and set deadlines within your
group to stay on track. We cannot set the deadlines for you because every project
develops at a different rate and with differing complexities. Based on your
deadlines, we will setup conference calls with each group to check-in. Remember
that this project will continue from now until graduation. You will get busy with
other courses and clinicals therefore, it’s essential to lay the foundation for success
with this project.
For the next 4 weeks, we want to plan/collect data on about 10 patients per week.
We want to finish data collection by the week 6, have our data analysis complete by
the next week in order to have our first rough draft completed by the due date in
week 8.
Week 2-5 of the course - ~10 patients per week
Week 6 - finish data collection
Week 7 - data analysis complete
Week 8 - first rough draft completed/due