Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

NCT06989099 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2024-0255NCI-2024-05054
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• Freedom from lymphedema (FFL)

  2 years

Study Arms (1)

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.

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

Interventions

Immediate Lymphatic Reconstruction (ILR)/ PROCEDURE

Given by Procedure

Postoperative Evaluations

Prophylactic Lymphovenous Bypass (pLVB) PROCEDURE

Given by Procedure

Postoperative Evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mark Schaverien, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Hull, MHA, BA, BSN, RN, CCRP

CONTACT

713-794-1247; sehull@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: September 24, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)