Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2029-08-01

Brief Summary

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

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Detailed Description

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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

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Lymphedema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Immediate Lymphatic Reconstruction (ILR)/

Intervention Type PROCEDURE

Given by Procedure

Prophylactic Lymphovenous Bypass (pLVB)

Intervention Type PROCEDURE

Given by Procedure

Interventions

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Immediate Lymphatic Reconstruction (ILR)/

Given by Procedure

Intervention Type PROCEDURE

Prophylactic Lymphovenous Bypass (pLVB)

Given by Procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No