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NCT06989099PHASE2Recruiting

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

M.D. Anderson Cancer Center

Start Date

9/24/2024

Completion Date

8/1/2029

Summary

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

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Immediate Lymphatic Reconstruction (ILR)/

PROCEDURE

Prophylactic Lymphovenous Bypass (pLVB)

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Conditions

Lymphedema

Locations

MD Anderson Cancer Center

Houston, Texas 77030

United States