This phase II trial is being done to learn if immediate lymphatic reconstruction at the time of axillary lymphadenectomy works in preventing lymphedema in patients with breast cancer. The lymphatic system is a network of tubes that carry fluid and disease-fighting cells from tissues in the body to the bloodstream. When someone has lymphedema, there is a blockage that leads to swelling because of fluid retention (build-up) in the arm. Some cancer patients get lymphedema, and others do not. Immediate lymphatic reconstruction (ILR), also termed prophylactic lymphovenous bypass (pLVB), is a microsurgical procedure that is used to improve lymphatic fluid movement in patients that undergo axillary lymphadenectomy as part of their breast cancer treatment. Reconstruction of the lymphatic system at the time of axillary lymphadenectomy may improve the flow in patients’ lymphatic system and reduce the risk of developing lymphedema in patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06989099.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Mark Schaverien
Phone: 713-794-1247
PRIMARY OBJECTIVE:
I. To determine the freedom from lymphedema (FFL) rate at 2 years postoperatively in patients with a diagnosis of inflammatory breast cancer (IBC) undergoing immediate lymphatic reconstruction (ILR) at the time of axillary lymph node dissection (ALND).
SECONDARY OBJECTIVES:
I. Estimate the proportion of patients who have lymphedema that persists at 2 years after ILR surgeries.
II. Associate numerically characterized longitudinal changes in lymphatic vessel anatomy and function, with near-infrared fluorescence lymphatic imaging (NIRF-LI) before and after ILR surgeries.
III. Determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ILR.
IV. Evaluate changes in systemic inflammatory mediators (cytokines/ chemokines) and systemic immune cell function affiliated with lymphedema development.
V. Evaluate correlations between relative limb volume change, lymphedema Index (LDex) score, patient-reported outcomes, NIRF-LI imaging metrics, and plasma cytokines/chemokines in patients that do or do not receive ILR, and in those that develop clinical lymphedema with those that do not.
OUTLINE:
Patients undergo ILR at the time of ALND. Patients also receive 12- 20 indocyanine green (ICG) solution injections intradermally and undergo NIRF-LI before surgery, then 6, 12, 18, and 24 months after surgery. Patients also undergo blood sample collection on study.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorMark Schaverien
