Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

Launched by M.D. ANDERSON CANCER CENTER · May 23, 2025

Keywords

ClinConnect Summary

The LILY Trial is a research study that aims to find out if fixing the lymphatic system during surgery for breast cancer can help prevent a condition called lymphedema. Lymphedema is swelling that can happen when lymph fluid builds up, often after lymph nodes are removed during cancer treatment. This trial is currently looking for participants aged 65 to 74 who have been diagnosed with invasive breast cancer and are scheduled for specific surgeries related to their treatment.

To be eligible for the study, participants need to be women aged 18 or older, able to give consent, and scheduled for a particular type of surgery called immediate lymphatic reconstruction or pLVB at the same time as their axillary lymphadenectomy (the removal of lymph nodes). Those who are pregnant, breastfeeding, or have certain medical conditions will not be able to participate. If you join the trial, you can expect to follow specific study guidelines and attend regular visits related to your treatment. This research could help improve care for future breast cancer patients by reducing the risk of lymphedema.

Gender

ALL

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.