Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: Immediate Lymphatic Reconstruction (ILR)/; Procedure: Prophylactic Lymphovenous Bypass (pLVB)

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sara Hull, MHA, BA, BSN, RN, CCRP; Phone Number: 713-794-1247; Email: sehull@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Md Anderson Cancer Center
      • Principal Investigator: Mark Schaverien, MD
      • Contact: Sara Hull, MHA, BA, BSN, RN, CCRP; Phone Number: 713-794-1247; Email: sehull@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

MD Anderson Cancer Center

Description

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 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.

Exclusion Criteria:

1. Patients known to be pregnant or breast-feeding.
2. Patients with known or suspected iodine or ICG hypersensitivity.
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 BMI >45kg/m2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)/; Given by Procedure; Procedure: Prophylactic Lymphovenous Bypass (pLVB); Given by Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Freedom from lymphedema (FFL)	2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Mark Schaverien, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2024-0255; NCI-2024-05054 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No