An interventional study of Indocyanine Green and Lymphangiography in Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma and Locally Advanced Breast Carcinoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
PRIMARY OBJECTIVES:
I. To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
SECONDARY OBJECTIVES:
I. Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
Patients will be eligible for inclusion if they fall into one for two groups:
Exclusion Criteria:
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Drug: Indocyanine Green · Procedure: Lymphangiography · Procedure: Lymphovenous Bypass
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Given IV
Also known as: ICG
Undergo lymphangiography
Also known as: Lymphography
Undergo LVB
Also known as: Lymphovenous Anastomosis
Volumetric diagnosis of lymphedema
If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
Time frame: 18 months
Incidence of lymphedema
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
Time frame: 18 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Inflammatory Breast Neoplasms→
M.D. Anderson Cancer Center