Houston, Texas 77030


Purpose:

This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.


Study summary:

PRIMARY OBJECTIVES: I. Determine incidence of patients who develop lymphedema following autologous breast reconstruction. SECONDARY OBJECTIVES: I. Determine the overall complications of prophylactic vascularized lymph node transfers. II. Compare the incidence of patients who develop lymphedema following autologous breast reconstruction among patients who had prophylactic lymph node transfer and a historical cohort who did not have prophylactic lymph node transfer. OUTLINE: Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery. After completion of study, patients are followed up for 2 weeks, at 3 and 6 months, and then at 1 and 2 years.


Criteria:

Inclusion Criteria: - Patients who have undergone treatment (mastectomy, axillary lymph node dissection [ALND], radiation and chemotherapy) for breast cancer and are seeking breast reconstruction Exclusion Criteria: - Patients that are known to be pregnant at the time of surgery - Patients with a known hypersensitivity to indocyanine green (ICG) and/or isosulfan blue (Lymphazurin)


NCT ID:

NCT03990610


Primary Contact:

Principal Investigator
Edward I Chang
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Edward I. Chang
Phone: 713-794-1247
Email: eichang@mdanderson.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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