Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
Phase: PHASE2
Conditions: Lymphedema
Sponsor: M.D. Anderson Cancer Center

Study Number 2024-0255
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Informed Consent/Authorization for Participation in Research
Title of Research Study:   
Lymphedema prevention through 
Immediate LYmphatic reconstruction 
(LILY) trial
Study Number:      
2024-0255
Principal Investigators: 
Mark Schaverien, MD, MB, ChB, MSc, 
MEd, FRCS 
Melissa Aldrich, MBA, PhD
_________________________
_____________________________
Participant’s Name
Medical Record Number 
Key Information
The following is a short summary of this study to help you decide whether or not to be a 
part of this study. More detailed information is listed later on in this form.
Why am I being invited to take part in a research study?
You are invited to take part in a research study because you will undergo possible 
immediate lymphatic reconstruction ILR, also termed prophylactic lymphovenous 
bypass (pLVB) at the time of your axillary lymphadenectomy for breast cancer. 
What should I know about a research study?

Someone will explain this research study to you.

Whether or not you take part is up to you.

You can choose not to take part.

You can agree to take part and later change your mind.

Your decision will not be held against you.

You can ask all the questions you want before you decide.
Why is this research being done?
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Study Number 2024-0255
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The lymphatic system is a network of tubes that carry fluid and disease-fighting cells 
from tissues in the body to the bloodstream.  When someone has lymphedema, there is 
a blockage that leads to swelling because of fluid retention (build-up) in the arm.  Some 
cancer patients get lymphedema, and others do not.  Immediate lymphatic 
reconstruction (ILR), also termed prophylactic lymphovenous bypass (pLVB), is a 
microsurgical procedure that is used to improve lymphatic fluid movement in patients 
that undergo axillary lymphadenectomy as part of their breast cancer treatment. 
This goal of this research study is to learn if reconstruction of the lymphatic system at 
the time of axillary lymphadenectomy can improve the flow in patients’ lymphatic system 
and reduce the risk of developing lymphedema.  
This is an investigational study. The imaging scans in this study are performed using 
FDA-approved and commercially available methods. It is investigational to use them to 
check if the lymphatic system is affected by microsurgery.
How long will the research last and what will I need to do?
You are expected to be in this research study for about 24 months. You will have 5 
study visits during this time. 
More detailed information about the study procedures can be found under “What 
happens if I agree to be in this research?”
Is there any way being in this study could be bad for me?
Before choosing to take part in this study, you should discuss with the study team any 
concerns you may have, including side effects, potential expenses, and time 
commitment.
More detailed information about the risks of this study can be found under “Is there any 
way being in this study could be bad for me? (Detailed Risks)”
Will being in this study help me in any way?
It cannot be promised that there will be any benefits to you or others from your taking 
part in this research. However, it is possible that the imaging on this study could find 
areas of your body where the lymphatic system is not working properly. Future patients 
may benefit from what is learned. There may be no benefits for you in this study.  
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What happens if I do not want to be in this research?
Participation in research is completely voluntary. You can decide to participate, not 
participate, or discontinue participation at any time without penalty or loss of your 
regular benefits.
You may choose to have ILR/ pLVB surgery without taking part in this study. You may 
choose not to have the procedure at all. These alternative treatments have risks and 
benefits that may be the same or different than those in this research study. The study 
doctor can discuss these alternative treatments, including their risks and benefits, with 
you.
Your alternative to participating in this research study is to not participate.
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Detailed Information
The following is more detailed information about this study in addition to the information 
listed above.
Who can I talk to if I have questions or concerns?
If you have questions, concerns, or complaints, or think the research has hurt you, talk 
Dr. Aldrich at 713-248-2642 or Dr. Schaverien at 713-794-1247.
This research has been reviewed and approved by an Institutional Review Board (IRB – 
an ethics committee that reviews research studies). You may talk to them at 713-792-
6477 or IRB_Help@mdanderson.org if:

Your questions, concerns, or complaints are not being answered by the research 
team.

You cannot reach the research team.

You want to talk to someone besides the research team.

You have questions about your rights as a research participant.

You want to get information or provide input about this research.
How many people will be in this study?
It is expected about 50 people at MD Anderson will be enrolled in this research study. 
What happens if I agree to be in this research?
Screening Tests     
Signing this consent form does not mean that you will be able to take part in this study. 
The following screening tests will help the doctor decide if you are eligible:

You will be checked for skin conditions at the sites where the dye being used for 
the imaging scans will be injected.

If you can become pregnant, you will have a urine pregnancy test. To take part in 
this study, you must not be pregnant.
The study doctor will discuss the screening test results with you. If the screening tests 
show that you are not eligible to take part in the study, you will not be enrolled. Other 
treatment options will be discussed with you.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
Study Procedures
If you agree to take part in this study, your clinic visit timing will be exactly the same 
time as would ordinarily be scheduled: before surgery, then 6, 12, 18, and 24 months 
after surgery. 
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At each visit:

Your arm volume will be measured using a non-invasive device called a 
perometer, and the amount of fluid in your arm will be measured using a non-
invasive bioimpedance spectroscopy device. 

You will complete 2 questionnaires either on paper or on a secured iPad about any 
symptoms that may have in your arm that may be a sign of lymphedema, and any 
affects these have on your quality of life. It should take about 5-10 minutes to 
complete all of the questionnaires. 

A picture of your arms may also be taken. 

Blood (about 3 tablespoons) will be drawn for biomarker testing. Biomarkers are 
found in the blood/tissue and may be related to your reaction to the study drug.

A member of the study staff will give you 12-20 injections of indocyanine green 
(ICG) dye into your arms. A red light (similar to a grocery store scanner) will then 
be pointed at the injected areas so the study staff can see how the dye spreads in 
your arm. 
o
You will wear protective glasses during this. 
o
The dye is removed from the body through the liver shortly after the 
injection.
o
A very small needle is used to help avoid discomfort. If needed, a 
numbing agent (such as ethyl chloride spray or lidocaine) may be applied 
to the skin before injection.

Your vital signs (heart rate, temperature, and blood pressure) will be checked 15 
minutes after the first injection and you will be monitored for side effects.
Each study visit should take about 2-3 hours.
Surgery
The surgery (ILR/ pLVB) will be performed exactly as normal as part of your standard 
care including the scheduling, and no additional procedures will be performed during 
the surgery that either increase the length of time your surgery takes or change your 
recovery from surgery. The study doctor will explain the surgery to you and answer all 
of your questions. You will also sign a separate consent form that explains the surgery 
in more detail, including its risks.
What are my responsibilities if I take part in this research?
If you take part in this research, there are no additional responsibilities for you outside of 
the usual standard of care.
What happens if I say yes, but I change my mind later?
You can leave the research at any time; it will not be held against you.
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If you withdraw from this study, you can still choose to be treated at MD Anderson. If 
you stop being in the research, already collected data may not be removed from the 
study database. You may be asked whether the study doctor can collect data from your 
routine medical care. If you agree, this data will be handled the same as research data. 
Is there any way being in this study could be bad for me? (Detailed 
Risks)
While on this study, you are at risk for side effects. These side effects will vary from 
person to person. The more commonly occurring side effects are listed in this form, as 
are rare but serious side effects. You should discuss these with the study doctor. You 
may also want to ask about uncommon side effects that have been observed in small 
numbers of patients but are not listed in this form. Many side effects go away shortly 
after the procedure, but in some cases side effects may be serious, long-lasting or 
permanent, and may even result in hospitalization and/or death.
Tell the study staff about any side effects you may have, even if you do not think they 
are related to the procedure.
Indocyanine Green Dye Side Effects 
It is not well known how often the following side effects of indocyanine green dye may 
occur.

headache

itching

sweating

hives

green stool color

life-threatening allergic 
reaction (such as 
difficulty breathing, low 
blood pressure, and/or 
organ failure)
You may experience slight discomfort from the injections.  If you choose to use a 
numbing agent to minimize the discomfort from injections, your skin may become numb, 
red, or itch for a short time where the cream or liquid is used. 
Blood draws may cause pain, bleeding, and/or bruising. You may faint and/or develop 
an infection with redness and irritation of the vein at the site where blood is drawn. 
Frequent blood collection may cause anemia (low red blood cell count), which may 
create a need for blood transfusions.
Questionnaires may contain questions that are sensitive in nature.  You may refuse 
to answer any question that makes you feel uncomfortable.  If you have concerns 
about completing the questionnaire, you are encouraged to contact your doctor or 
the study chair.
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Although every effort will be made to keep study data safe, there is a chance that your 
personal health information could be lost or stolen, which may result in a loss of 
confidentiality. All study data will be stored in password-protected computers and/or 
locked file cabinets and will continue to be stored securely after the study. 
In addition to these risks, this research may hurt you in ways that are unknown. These 
may be a minor inconvenience or may be so severe as to cause death.
You will be told about any new information that may affect your health, welfare, or 
choice to stay in the research.
Pregnancy Related Risks
Taking part in this study can result in risks to an unborn or breastfeeding baby, so you 
should not become pregnant or breastfeed a baby while on this study. You must use 
birth control during the study if you are sexually active. Examples of medically accepted 
birth control are pills, a condom or a diaphragm used with foam, or an intrauterine 
device (IUD), among others. Talk to the study doctor about what method may work best 
for you and your partner.
If you are pregnant, you will not be enrolled on this study. If you become pregnant or 
suspect that you are pregnant, you must tell your doctor right away.
Getting pregnant will result in your removal from this study.  
Will it cost anything to be in this study? Will I be paid to be in this 
study?
There will be no additional cost to you to take part in this study. The ILR/ pLVB surgery 
itself is not part of the study, and you and/or your insurance provider will be responsible 
for the cost of this surgery as normal.
Certain tests, procedures, and/or drugs that you may receive as part of this study may 
be without cost to you because they are for research purposes only. However, your 
insurance provider and/or you may be financially responsible for the cost of care and 
treatment of any complications resulting from the research tests, procedures, and/or 
drugs. Standard medical care that you receive under this research study will be billed to 
your insurance provider and/or you in the ordinary manner. Before taking part in this 
study, you may ask about which parts of the research-related care may be provided 
without charge, which costs your insurance provider may pay for, and which costs may 
be your responsibility. You may ask that a financial counselor be made available to you 
to talk about the costs of this study.
Taking part in this study may result in added costs to you (such as transportation, 
parking, meals, or unpaid leave from work). You may have to pay for medication 
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prescribed to treat or prevent side effects, and you may have to visit the clinic/hospital 
more often than if you were not participating in this study.
If you have insurance, talk to your insurance provider and make sure that you 
understand what your insurance pays for and what it does not pay for if you take part in 
this study. Also, find out if you need approval from your plan before you can take part in 
the study. 
You may ask that a financial counselor be made available to you to talk about the costs 
of this study.
You will receive up to $250 ($50 for each study visit) in gift cards for your time and effort 
if you complete all 5 study visits.
What happens to the information collected for the research?
Efforts will be made to limit the use and disclosure of your personal information, 
including research study and medical records, to people who need to review this 
information. Complete secrecy cannot be promised. Organizations that may inspect and 
copy your information include the IRB and other representatives of this organization. 
Any personal information that could identify you will be removed or changed before data 
are shared with other researchers or results are made public.
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, 
or samples that may identify you in any action or suit unless you say it is okay. They 
also cannot provide them as evidence unless you have agreed. This protection includes 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An 
example would be a court subpoena.
There are some important things that you need to know. The Certificate DOES NOT 
stop reporting that federal, state or local laws require. Some examples are laws that 
require reporting of child or elder abuse, some communicable diseases, and threats to 
harm yourself or others. The Certificate CANNOT BE USED to stop a sponsoring United 
States federal or state government agency from checking records or evaluating 
programs. The Certificate DOES NOT stop disclosures required by the federal Food 
and Drug Administration (FDA). The Certificate also DOES NOT prevent your 
information from being used for other research if allowed by federal regulations.
Researchers may release information about you when you say it is okay. For example, 
you may give them permission to release information to insurers, medical providers or 
any other persons not connected with the research. The Certificate of Confidentiality 
does not stop you from willingly releasing information about your involvement in this 
research. It also does not prevent you from having access to your own information.   
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The sponsor, monitors, auditors, the IRB, and the Food and Drug Administration will be 
granted direct access to your medical records to conduct and oversee the research. By 
signing this document, you are authorizing this access. The results of this research may 
be published. However, your name and other identifying information will be kept 
confidential.
Federal law provides additional protections of your medical records and related health 
information. These are described below.
Will my data or samples be used for future research?
Your personal information and/or samples are being collected as part of this study. 
These data and/or samples may be used by researchers at MD Anderson or shared 
with other researchers and/or institutions for use in future research.
In some cases, all of your identifying information may not be removed before your data 
or research samples are used for future research. If future research is performed at MD 
Anderson, the researchers must get approval from the MD Anderson IRB before your 
data and/or research samples can be used. At that time, the IRB will decide whether or 
not further permission from you is required. If this research is not performed at MD 
Anderson, MD Anderson will not have oversight of any data and/or samples.
If identifiers are removed from your identifiable private information or identifiable 
samples that are collected during this research, that information or those samples could 
be used for future research studies or shared with another researcher for future 
research studies without your additional informed consent.
Some of your specimens and genetic and/or health information might also be placed 
into one or more external publicly-accessible scientific databases.  Your name and 
other information that could directly identify you (such as your address or social 
security number) will never be placed into these external databases.  A researcher 
who wants to study information from these databases must have an approved study 
and work with the group overseeing the database to obtain the information.
Can I be removed from the research study without my permission?
The person in charge of the research study or the sponsor can remove you from the 
research study without your approval. Possible reasons for removal include if you enroll 
on the study but do not undergo any surgery, if you do not attend the study evaluations 
after surgery, or if you develop recurrence and require chemotherapy or develop serious 
illness.
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What happens if I get hurt from being in this study?
If you get sick or hurt and it is related to your participation in this study, you will be given 
care at MD Anderson (if you are at the clinic when you are sick or hurt).  If you get hurt 
or sick and you are not at the clinic (for example, you are at home or at another doctor’s 
office):

call your personal doctor right away (or in an emergency, call 911)

tell your personal doctor or ER staff that you are in this study (try to give them a 
copy of this consent form or show them your participant card) 

call Dr. Aldrich at 713-248-2642 or Dr. Schaverien at 713-794-1247; or call 713-
792-2121 (24 hours)  
You will not be reimbursed for expenses or compensated financially by MD Anderson 
for this injury. Costs of treatment received because you were hurt or sick will be billed to 
you or your insurance company. No other form of payment is available. 
You may also contact the MD Anderson IRB at 713-792-6477 with questions about 
study-related injuries. By signing this consent form, you are not giving up any of your 
legal rights.
What else do I need to know?
This research is being funded by National Institutes of Health (NIH)/ National Cancer 
Institute (NCI).
Dr. John C. Rasmussen (Study Collaborator) and Dr. Eva M. Sevick-Muraca are 
inventors of the imaging system that will be used in this study, and a patent has been 
issued for the imaging system.  As such, Drs. Rasmussen and Sevick-Muraca could 
financially benefit from the outcome of this study in the future.
MD Anderson may benefit from your participation and/or what is learned in this study.
Your information and samples (both identifiable and de-identified) may be used to 
create products or to deliver services, including some that may be sold and/or make 
money for others. If this happens, there are no plans to tell you, or to pay you, or to give 
any compensation to you or your family.
Most tests done on samples in research studies are only for research and have no clear 
meaning for health care. If the research with your identifiable information or samples 
gives results that do have meaning for your health, the researchers will not contact you 
to let you know what they have found. If the researchers return genetic test results to 
you, it may be because they think you could have a health risk and want to recommend 
that the test should be re-done by a certified clinical laboratory to check the results. If 
this happens, then you may want to get a second test from a certified clinical laboratory, 
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consult your own doctor, or get professional genetic counseling. You may have to pay 
for those additional services yourself.
This research study involves testing of small pieces of the RNA (ribonucleic acid) and 
the DNA (deoxyribonucleic acid) of your immune cells.  We will not be performing whole 
genome sequencing and we will NOT look at RNA or DNA parts that can be used to 
identify you or family members.
Authorization for Use and Disclosure of Protected Health Information 
(PHI):
A. During the course of this study, MD Anderson will be collecting and using your PHI, 
including identifying information, information from your medical record, and study 
results. For legal, ethical, research, and safety-related reasons, your doctor and the 
research team may share your PHI with:

Federal agencies that require reporting of clinical study data (such as the FDA, 
National Cancer Institute [NCI], and OHRP)

The IRB and officials of MD Anderson

The NIH/NCI, who is a sponsor or supporter of this study, and/or any future 
sponsors/supporters of the study, and/or licensees of the study technology

Study monitors and auditors who verify the accuracy of the information

Individuals who put all the study information together in report form
Study sponsors and/or supporters receive limited amounts of PHI. They may also 
view additional PHI in study records during the monitoring process. MD Anderson’s 
contracts require sponsors/supporters to protect this information and limit how they 
may use it. 
The results of this research may be published in scientific journals or presented at 
medical meetings, but your identity will not be disclosed. 
B. Signing this consent and authorization form is optional but you cannot take part in 
this study or receive study-related treatment if you do not agree and sign.
C. MD Anderson will do its best to protect the privacy of your records, but it is possible 
that once information is shared with people listed on this form, it may be released to 
others. If this happens, your information may no longer be protected by federal law.
D. The permission to use your PHI will continue indefinitely unless you withdraw your 
authorization in writing. Instructions on how to do this can be found in the MD 
Anderson Notice of Privacy Practices (NPP) or you may contact the Chief Privacy 
Officer at 713-745-6636. If you withdraw your authorization, you will be removed 
from the study and the data collected about you up to that point can be used and 
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included in data analysis. However, no further information about you will be 
collected.
E. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify 
you. At most, the Web site will include a summary of the results. You can search this 
Web site at any time.
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CONSENT/AUTHORIZATION
I understand the information in this consent form. I have had a chance to read the 
consent form for this study, or have had it read to me. I have had a chance to think 
about it, ask questions, and talk about it with others as needed. I give the study chair 
permission to enroll me on this study. By signing this consent form, I am not giving up 
any of my legal rights. I will be given a signed copy of this consent document.
________________________________________
_______
SIGNATURE OF PARTICIPANT
DATE
_________________________________
PRINTED NAME OF PARTICIPANT
WITNESS TO CONSENT
I was present during the explanation of the research to be performed under this 
protocol. 
_____________________________________________________
_________
SIGNATURE OF WITNESS TO THE VERBAL CONSENT 
DATE
PRESENTATION (OTHER THAN PHYSICIAN OR STUDY CHAIR)
A witness signature is only required for non-English speakers utilizing the 
short form consent process (VTPS) and patients who are illiterate.
_____________________________________________________
PRINTED NAME OF WITNESS TO THE VERBAL CONSENT
PERSON OBTAINING CONSENT
I have discussed this research study with the participant and/or his or her authorized 
representative, using language that is understandable and appropriate.  I believe that I 
have fully informed this participant of the nature of this study and its possible benefits 
and risks and that the participant understood this explanation.
______________________________________________
_________
PERSON OBTAINING CONSENT 
DATE
______________________________________________
PRINTED NAME OF PERSON OBTAINING CONSENT
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TRANSLATOR
I have translated the above informed consent as written (without additions or 
subtractions) into
and assisted the people
(Name of Language)
obtaining and providing consent by translating all questions and responses during the 
consent process for this participant.
_____________________      _______________________________
________
NAME OF TRANSLATOR
SIGNATURE OF TRANSLATOR
DATE
   Please check here if the translator was a member of the research team.  (If 
checked, a witness, other than the translator, must sign the witness line.)
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