Mapping Lymphatic Drainage in Breast Cancer Survivors

This observational study aims to understand how the lymphatic system (a network of vessels that helps drain fluid and fight infection) in the arm works, specifically looking at an "alternate pathway" called the Mascagni-Sappey (M-S) pathway. Researchers will use imaging techniques like ICG lymphography (a test using a special dye to visualize lymph vessels) and lymphoscintigraphy with SPECT/CT (another imaging method to track lymphatic flow) to map this pathway. They are studying women who have had breast cancer treatment, including lymph node removal, but did not develop lymphedema (swelling caused by lymphatic system blockage). The goal is to see if variations in this pathway can explain why some women don't get lymphedema after breast cancer treatment. This study is currently unclear on its recruitment status and does not involve any specific interventions or drugs.

Study design
This is an observational study planning to enroll 142 women. It is not a randomized or blinded study.
What's involved
Participants will have imaging tests, including ICG lymphography and lymphoscintigraphy, during one study visit. These tests involve injections and imaging at different time points.
Compensation
Not stated in the trial record.
Follow-up
Lymphatic pathway anatomy will be measured immediately, 30 minutes, and 2 hours after injections during the single study visit.

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NCT05253352

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

Recruiting
Not specifiedAges 18+Observational
Beth Israel Deaconess Medical Center
~142 participants
Updated 2026-03-11 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lymphatic pathway anatomy of the upper extremity
Measured over Study Visit 1: Immediately after ICG lymphography injections
+6 more outcomes measured
Lymphatic System
1 sites across 1 states
Massachusetts1
  • Dhruv Singhal, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

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Eligibility criteria

Inclusion

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

Prior history of bilateral lymph node surgery
Prior history of other surgical procedures of the affected 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
Current active cancer
  • Lymphatic pathway anatomy of the upper extremityStudy Visit 1: Immediately after ICG lymphography injections

    Indocyanine green (ICG) lymphography of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremityStudy Visit 1: 30 min after lymphoscintigraphy tracer injection

    Lymphoscintigraphy scans of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremityStudy Visit 1: 2 hours after lymphoscintigraphy tracer injection

    Lymphoscintigraphy scans of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremity (SPECT/CT)Study Visit 1: 2 hours after lymphoscintigraphy tracer injection

    SPECT/CT lymphoscintigraphy scans of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremityStudy Visit 2: 30 min after lymphoscintigraphy tracer injection

    Lymphoscintigraphy scans of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremityStudy Visit 2: 2 hours after lymphoscintigraphy tracer injection

    Lymphoscintigraphy scans of bilateral upper arms

  • Lymphatic pathway anatomy of the upper extremity (SPECT/CT)Study Visit 2: 2 hours after lymphoscintigraphy tracer injection

    SPECT/CT lymphoscintigraphy scans of bilateral upper arms