Mapping and Quantifying Lymphatic Drainage of the Arm's Alternate Pathway

  • STATUS
    Recruiting
  • End date
    Aug 19, 2025
  • participants needed
    142
  • sponsor
    Beth Israel Deaconess Medical Center
Updated on 4 October 2022
Accepts healthy volunteers

Summary

Using indocyanine green (ICG) lymphography and lymphoscintigraphy with SPECT/CT imaging, the aim is to evaluate the anatomy of the lymphatic system pathway in two separate populations: healthy female volunteers and women with a history of breast cancer who did not develop lymphedema.

Description

Breast Cancer Related Lymphedema (BCRL) affects 1.2 million patients in the United States and has no cure. The symptoms of lymphedema include fatigue, tightness, pain, and life-threatening infections. However, two-thirds of women undergoing breast cancer treatment with the highest risk factors for developing lymphedema do not develop the disease. While there is no explanation for this finding, one hypothesis is that normal anatomic variations of the lymphatic system pre-dispose certain women to developing lymphedema after breast cancer treatment. Specifically, the main back-up lymphatic pathway of the arm, the Mascagni-Sappey (M-S) pathway, is variably present in cadaver studies and avoids areas that are usually damaged with breast cancer treatment. Moreover, when present in these cadaver studies, the M-S pathway has variable anatomic connections which can impact its ability to drain the arm effectively. The investigators hypothesize that, utilizing modern imaging techniques, the investigators can define the anatomy of the M-S pathway and its variations in normal women and in breast cancer survivors who have undergone high risk breast cancer treatment and did not develop lymphedema. Utilizing this information, the investigators will be able to predict which variations predispose women to develop lymphedema. Finally, the investigators will develop a novel method of non-invasive intraoperative optical imaging to assess the function of this pathway during breast cancer operations to predict the patient's risk of developing lymphedema. The ability to evaluate real-time lymphatic function would allow cancer teams to implement preventive interventions in high risk patients. As the most common cause of lymphedema in the United States is secondary to cancer procedures, this model of lymphedema prevention could be widely applied to the treatment of other high risk cancer populations including gynecologic cancers, urologic cancers, skin cancers, and sarcomas.

The investigators will use ICG lymphography and lymphoscintigraphy with SPECT/CT (single-photon emission computed tomography) imaging to evaluate the anatomy of the M-S pathway in two separate populations:

Group 1: The research study staff will recruit healthy female volunteers without a history of lymphedema or ALND (axillary lymph node dissection) surgery to map the normal anatomy of the M-S pathway. The investigators hope to quantify the percentage of women who do not have this pathway present, do not have peripheral connections between the M-S pathway and the forearm, and/or whose terminal M-S pathway draining nodal basins are in the axilla.

Group 2: Research study staff will measure changes that occur in the M-S pathway anatomy in women at least 2 years status-post ALND surgery without developing lymphedema in the time following their surgery (Aim 2) using the same methodology. By understanding the M-S pathway anatomy in relation to the main lymphatic drainage pathway of the forearm in the setting of an ALND without lymphedema the investigators can gain critical insight about which patients are at the highest risk of developing BCRL and why this is more likely to occur in some patients than others.

Details
Condition Lymphatic System
Clinical Study IdentifierNCT05253352
SponsorBeth Israel Deaconess Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Prior history of bilateral lymph node surgery
Prior history of other surgical procedures of either upper extremity besides the axillary management for breast cancer treatment
Prior history of chronic inflammatory conditions (e.g. rheumatoid arthritis)
Prior history of filarial infections
Prior history of lymphedema
Patient-reported pregnancy
Patients who are breastfeeding
Iodine allergy
Prior history of upper extremity deep vein thrombosis
Prior history of congestive heart failure
Prior history of venous thoracic outlet syndrome
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