Status:

RECRUITING

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

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Lymphatic System

Eligibility:

FEMALE

18+ years

Brief 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 ...

Detailed 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....

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

Key Trial Info

Start Date :

April 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT05253352

Start Date

April 1 2022

End Date

December 1 2025

Last Update

October 17 2025

Active Locations (1)

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1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215