LymphedemaPhase 2NCT06989099
Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
A Phase 2 study testing Immediate Lymphatic Reconstruction (ILR)/ and Prophylactic Lymphovenous Bypass (pLVB) in people with Lymphedema, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- Immediate Lymphatic Reconstruction (ILR)/ and Prophylactic Lymphovenous Bypass (pLVB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2024to 1 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with IBC.
- Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
- Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
- Female subjects at least 18 years old and capable of providing consent to participate.
- Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.
Who cannot join
- Patients known to be pregnant or breast-feeding.
- Patients with known or suspected iodine or ICG hypersensitivity.
- Patients unable to remain stationary for one hour.
- Active cellulitis.
- Subjects with a preoperative clinical lymphedema diagnosis.
- Subjects undergoing bilateral ALND.
- Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
- Patients with BMI >45kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sara Hull, MHA, BA, BSN, RN, CCRP, 713-794-1247, sehull@mdanderson.org
Mark Schaverien, MD
About this study
Official title: Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Read the detailed description
Primary Objectives
- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.
Secondary Objectives
- Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries.
- Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
- Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
- Conditions
- Lymphedema
- Being tested
- Immediate Lymphatic Reconstruction (ILR)/, Prophylactic Lymphovenous Bypass (pLVB)
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Lymphatic Reconstruction (ILR)/Procedure or surgery
Given by Procedure
Prophylactic Lymphovenous Bypass (pLVB)Procedure or surgery
Given by Procedure
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Evaluations | Experimental | Participants who agree to take part in this study, 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. Each study visit should take about 2-3 hours. Receives: Procedure: Immediate Lymphatic Reconstruction (ILR)/; Procedure: Prophylactic Lymphovenous Bypass (pLVB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from lymphedema (FFL)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start24 Sep 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Schaverien, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989099
- Sponsor's protocol ID
- 2024-0255
- Other IDs
- NCI-2024-05054
- Status last verified
- Sep 2026
- First submitted
- 9 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial
- ClinicalTrials.gov ID
- NCT06989099
- Acronym / sponsor ID
- 2024-0255
- Conditions
- Lymphedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
Detailed description
Primary Objectives
- To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in participants with a diagnosis of IBC undergoing ILR at the time of ALND.
Secondary Objectives
- Estimate the proportion of participants who have lymphedema that persists at 2 years after ILR surgeries.
- Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
- Evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Evaluations | Experimental | Procedure: Immediate Lymphatic Reconstruction (ILR)/, Procedure: Prophylactic Lymphovenous Bypass (pLVB)Participants who agree to take part in this study, 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. Each study visit should take about 2-3 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with IBC.
- Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
- Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
- Female subjects at least 18 years old and capable of providing consent to participate.
- Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.
Key exclusion criteria (8 listed)
- Patients known to be pregnant or breast-feeding.
- Patients with known or suspected iodine or ICG hypersensitivity.
- Patients unable to remain stationary for one hour.
- Active cellulitis.
- Subjects with a preoperative clinical lymphedema diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Lymphatic Reconstruction (ILR)/Given by Procedure | Procedure or surgery | Postoperative Evaluations |
| Prophylactic Lymphovenous Bypass (pLVB)Given by Procedure | Procedure or surgery | Postoperative Evaluations |
Primary outcome
Freedom from lymphedema (FFL)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Schaverien, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immediate Lymphatic Reconstruction (ILR)/ and Prophylactic Lymphovenous Bypass (pLVB) in people with Lymphedema, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Hull, MHA, BA, BSN, RN, CCRP (713-794-1247, sehull@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from lymphedema (FFL) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.