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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
- Immediate Lymphatic Reconstruction (ILR)/ (procedure)
- Prophylactic Lymphovenous Bypass (pLVB) (procedure)
Sponsor: M.D. Anderson Cancer Center · Participants: 50 · Started: Sep 24, 2024
Contact the study team
- Sara Hull, MHA, BA, BSN, RN, CCRP · Phone: 713-794-1247
Official record on ClinicalTrials.gov — NCT06989099
Locations in the U.S.
| Texas | MD 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.