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 2026-11-10.
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.
112 studies on the registry are indexed under Inflammatory Breast Neoplasms; 7 are open to participants now.
This study's planned enrollment of 252 is above the median of 58 across 96 interventional studies indexed under Inflammatory Breast Neoplasms.
Browse Inflammatory Breast Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients will be eligible for inclusion if they fall into one for two groups:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Inflammatory Breast Neoplasms →