Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Lymphedema

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06989099

2024-0255

NCI-2024-05054 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Postoperative Evaluations

Experimental group

Description:

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.

Treatment:

Procedure: Prophylactic Lymphovenous Bypass (pLVB)

Procedure: Immediate Lymphatic Reconstruction (ILR)/