UHFUS Characterization of Normal Lymphatic Anatomy

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07677839
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine green (ICG) solution injection — PROCEDURE
    0.1cc of 2.5 mg/cc Indocyanine green (ICG) solution will be injected intradermally at the 1st and 4th webspaces of the hand, and radial and ulnar volar wrist areas.
  • Ultra-High Frequency Ultrasound — DEVICE
    UHFUS will capture still images at specific landmarks along the wrist-to-elbow axis to characterize lymphatic channels. The following quantitative data of lymphatic channels will be captured: 1\. Outer diameter (i.e., total diameter including wall and lumen); 2. Inner diameter (i.e., diameter of the lumen only); and 3. Wall thickness (i.e., the thickness of the lymphatic channel wall)

Study Details

This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.

Key Dates

Start date
Jun 17, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2036
Completion
Sep 1, 2036

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye
    Indocyanine green (ICG) solution will be injected intradermally, followed by ultra-high-frequency ultrasound imaging/mapping to characterize lymphatic channels.

Primary Outcome Measure

Outer lymphatic vessel diameter [ Time Frame: During ultra-high frequency ultrasound imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis HealthSacramentoCalifornia95816
Shari Nichols
(916) 734-7289
Ara Salibian, MD (PRINCIPAL_INVESTIGATOR)

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