ClinicalTrials.gg
RecruitingNCT06989099Updated Sep 25, 2026

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

A Phase 2 interventional study of Immediate Lymphatic Reconstruction (ILR)/ and Prophylactic Lymphovenous Bypass (pLVB) in Lymphedema, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Sep 2024, registered May 2025).
  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Lymphedema

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03

In context

Lymphedema

529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 369 interventional studies indexed under Lymphedema.

Browse Lymphedema studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants diagnosed with IBC.
  2. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
  3. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
  4. Female subjects at least 18 years old and capable of providing consent to participate.
  5. Females of must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of for a period of one month following the study.

Exclusion criteria

Exclusion Criteria:

  1. Patients known to be pregnant or breast-feeding.
  2. Patients with known or suspected iodine or ICG .
  3. Patients unable to remain stationary for one hour.
  4. Active cellulitis.
  5. Subjects with a preoperative clinical lymphedema diagnosis.
  6. Subjects undergoing bilateral ALND.
  7. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
  8. Patients with >45kg/m2.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Postoperative Evaluations

    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.

    Procedure: Immediate Lymphatic Reconstruction (ILR)/ · Procedure: Prophylactic Lymphovenous Bypass (pLVB)

Interventions

  • ProcedureImmediate Lymphatic Reconstruction (ILR)/

    Given by Procedure

  • ProcedureProphylactic Lymphovenous Bypass (pLVB)

    Given by Procedure

06

What researchers measure

Primary outcomes

  1. Freedom from lymphedema (FFL)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Aug 2028, 46 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2025
First posted
May 25, 2025
StartActual
Sep 24, 2024
Primary completionEst.
Aug 1, 2028
CompletionEst.
Aug 1, 2029
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06989099
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Sep 24, 2024
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Sara Hull, MHA, BA, BSN, RN, CCRP
Contact
sehull@mdanderson.org
713-794-1247
Mark Schaverien, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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