Status:
RECRUITING
Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Lymphedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06989099
Start Date
September 24 2024
End Date
August 1 2029
Last Update
July 1 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030