RecruitingPhase 2

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

United States50 participantsStarted 2024-09-24

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participants diagnosed with IBC.
✓. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
✓. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
✓. Female subjects at least 18 years old and capable of providing consent to participate.
✓. 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.

✕. Patients known to be pregnant or breast-feeding.
✕. Patients with known or suspected iodine or ICG hypersensitivity.
✕. Patients unable to remain stationary for one hour.
✕. Active cellulitis.
✕. Subjects with a preoperative clinical lymphedema diagnosis.
✕. Subjects undergoing bilateral ALND.
✕. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
✕. Patients with BMI \>45kg/m2.

Freedom from lymphedema (FFL)

Timeframe: 2 years

NCT IDNCT06989099

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-08-01

Sara Hull, MHA, BA, BSN, RN, CCRP

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participants diagnosed with IBC.
✓. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
✓. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
✓. Female subjects at least 18 years old and capable of providing consent to participate.
✓. 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.

✕. Patients known to be pregnant or breast-feeding.
✕. Patients with known or suspected iodine or ICG hypersensitivity.
✕. Patients unable to remain stationary for one hour.
✕. Active cellulitis.
✕. Subjects with a preoperative clinical lymphedema diagnosis.
✕. Subjects undergoing bilateral ALND.
✕. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
✕. Patients with BMI \>45kg/m2.