Variations in Lymphatic Anatomy and Function of the Arm’s Alternate Lymphatic Pathway

Status: active

This study investigates variations in lymphatic anatomy (different arrangements of vessels, or pathways, through which excess fluid travels out of the arms) and function that predispose women to lymphedema in patients who do not have breast cancer. The lymphatic system is an interconnected system of vessels that transports excess fluid alongside arteries and veins, in addition to playing a role in the immune system. Lymphedema is a disease that causes debilitating swelling in the arms or legs, usually as a result of malfunction, injury or changes caused by other medical treatments (like therapy or surgery to treat breast cancer) to the lymphatic system. Imaging scans like lymphography and single photon tomography and computed tomography (SPECT/CT) lymphoscintigraphy may help identify the variations that occur naturally in the anatomy of breast cancer patients and healthy volunteers, which may aid researchers in learning more about how these alternative pathways in the lymphatics of the upper extremity (arms) contribute to the function of the lymphatic system.

Inclusion Criteria

GROUP 1: Female
GROUP 1: Ability to understand the protocol and willingness to participate
GROUP 1: At least 18 years of age
GROUP 2: Female
GROUP 2: History of breast cancer treatment including ALND – defined by removal of >= 10 lymph nodes – more than 2 years before study participation
GROUP 2: Ability to understand the protocol and willingness to participate
GROUP 2: At least 18 years of age

Exclusion Criteria

GROUP 1: Prior history of breast cancer
GROUP 1: Prior history of radiotherapy to the axilla, upper extremity, head or neck
GROUP 1: Prior history of chemotherapy
GROUP 1: Prior history of surgical procedures of upper extremity including the axilla
GROUP 1: Prior history of chronic inflammatory conditions (e.g. rheumatoid arthritis)
GROUP 1: Prior history of filarial infections
GROUP 1: Prior history of lymphedema, including definition by an L-Dex score > 10 or < -10 and/or volume difference between extremities of > 10%
GROUP 1: Treatment to the upper extremity for swelling less than 1 year before study participation including but not limited to use of compression, manual lymphatic drainage, visit to a certified lymphedema therapist
GROUP 1: Patient-reported pregnancy
GROUP 1: Patients who are breastfeeding their children
GROUP 1: Iodine allergy
GROUP 1: Prior history of upper extremity deep vein thrombosis
GROUP 1: Prior history of congestive heart failure
GROUP 1: Prior history of venous thoracic outlet syndrome
GROUP 2: Current active cancer
GROUP 2: Prior history of bilateral lymph node surgery
GROUP 2: Prior history of other surgical procedures of the affected upper extremity besides the axillary management for breast cancer treatment
GROUP 2: Prior history of chronic inflammatory conditions (e.g. rheumatoid arthritis)
GROUP 2: Prior history of filarial infections
GROUP 2: Prior history of lymphedema, including definition by an L-Dex score > 10 or < -10 and/or volume difference between extremities of > 10%
GROUP 2: Treatment to the upper extremity for swelling less than 1 year before study participation including but not limited to use of compression, manual lymphatic drainage, visit to a certified lymphedema therapist
GROUP 2: Patient-reported pregnancy
GROUP 2: Patients who are breastfeeding
GROUP 2: Iodine allergy
GROUP 2: Prior history of upper extremity deep vein thrombosis
GROUP 2: Prior history of congestive heart failure
GROUP 2: Prior history of venous thoracic outlet syndrome

PRIMARY OBJECTIVES:

I. To define an alternative lymphatic route in the upper extremity, known as the Mascagni-Sappey pathway (M-S pathway) anatomy, in healthy female volunteers.

II. To define the M-S pathway anatomy after axillary lymph node dissection (ALND) surgery in breast cancer patients without lymphedema.

OUTLINE: This is an observational study.

GROUP 1: Healthy participants receive indocyanine green (ICG) intradermally (ID) and undergo lymphography and venous ultrasound on day 1. Participants also receive technetium Tc 99m-labeled tilmanocept ID and undergo SPECT/CT lymphoscintigraphy scan on day 1 and again between 3 and 14 days later.

GROUP 2: Breast cancer patients undergo ICG lymphography and technetium Tc 99m-labeled tilmanocept SPECT/CT lymphoscintigraphy scan and venous ultrasound as in Group 1.

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Variations in Lymphatic Anatomy and Function of the Arm’s Alternate Lymphatic Pathway

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Variations in Lymphatic Anatomy and Function of the Arm’s Alternate Lymphatic Pathway

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