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Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

RecruitingPhase 2

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: M.D. Anderson Cancer Center · Participants: 50 · Started: Sep 24, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06989099

Locations in the U.S.

TexasMD Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.