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

NCT05253352 | Recruiting

• 2 other identifiers: 2021P0002091R01HL157991-01
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

anatomy; lymphatic system

Outcome Measures

Primary Outcomes (7)

• Lymphatic pathway anatomy of the upper extremity

  Indocyanine green (ICG) lymphography of bilateral upper arms

  Study Visit 1: Immediately after ICG lymphography injections

• Lymphatic pathway anatomy of the upper extremity

  Lymphoscintigraphy scans of bilateral upper arms

  Study Visit 1: 30 min after lymphoscintigraphy tracer injection

• Lymphatic pathway anatomy of the upper extremity

  Lymphoscintigraphy scans of bilateral upper arms

  Study Visit 1: 2 hours after lymphoscintigraphy tracer injection

• Lymphatic pathway anatomy of the upper extremity (SPECT/CT)

  SPECT/CT lymphoscintigraphy scans of bilateral upper arms

  Study Visit 1: 2 hours after lymphoscintigraphy tracer injection

• Lymphatic pathway anatomy of the upper extremity

  Lymphoscintigraphy scans of bilateral upper arms

  Study Visit 2: 30 min after lymphoscintigraphy tracer injection

• Lymphatic pathway anatomy of the upper extremity

  Lymphoscintigraphy scans of bilateral upper arms

  Study Visit 2: 2 hours after lymphoscintigraphy tracer injection

• Lymphatic pathway anatomy of the upper extremity (SPECT/CT)

  SPECT/CT lymphoscintigraphy scans of bilateral upper arms

  Study Visit 2: 2 hours after lymphoscintigraphy tracer injection

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a history of breast cancer treatment including axillary lymph node dissection (ALND) more than 2 years prior to study participation, who did not develop lymphedema.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

• Dhruv Singhal, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Chen, BS

CONTACT

6176327043; achen22@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 23, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)