Recruiting

Lymphatic Mapping

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT05253352

Conditions

Lymphatic System

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

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 volunteers and women with a history of breast cancer who did not develop lymphedema.

Conditions

Lymphatic System

Study ID

NCT05253352

Start date

Apr 1, 2022

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 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

Study Design

Enrollment

142 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers

Healthy female volunteers with no history of lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging

Women with breast cancer who did not develop lymphedema

Women who have had an axillary lymph node dissection (ALND) and did not develop lymphedema. Physical therapy examination, ICG lymphography, venous ultrasound and lymphoscintigraphy with SPECT/CT imaging

Primary outcome measure

  • Lymphatic pathway anatomy of the upper extremity [ Time Frame: Study Visit 1: Immediately after ICG lymphography injections ]
  • Lymphatic pathway anatomy of the upper extremity [ Time Frame: Study Visit 1: 30 min after lymphoscintigraphy tracer injection ]
  • Lymphatic pathway anatomy of the upper extremity [ Time Frame: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection ]
  • Lymphatic pathway anatomy of the upper extremity (SPECT/CT) [ Time Frame: Study Visit 1: 2 hours after lymphoscintigraphy tracer injection ]
  • Lymphatic pathway anatomy of the upper extremity [ Time Frame: Study Visit 2: 30 min after lymphoscintigraphy tracer injection ]
  • Lymphatic pathway anatomy of the upper extremity [ Time Frame: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection ]
  • Lymphatic pathway anatomy of the upper extremity (SPECT/CT) [ Time Frame: Study Visit 2: 2 hours after lymphoscintigraphy tracer injection ]

Central Contacts and Locations

Central contacts

Angela Chen, BS

6176327043achen22@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Dhruv Singhal, MD

617-632-7855

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • anatomy
  • lymphatic system

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-11.