Recruiting

UHFUS with ICG

Sponsor:

UCLA

Code:

NCT07677839

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine green (ICG) solution injection

Ultra-High Frequency Ultrasound

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT07677839

Start date

Jun 17, 2026

Status verified date

Jun, 2026

Completion date

Sep 1, 2036

Anticipated

Primary completion date

Mar 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1\. Aged 18+ at the time of consent.
  • 2\. Confirmed breast cancer diagnosis
  • 3\. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
  • 4\. Provision of a signed and dated informed consent form.
  • 5\. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

  • 1\. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
  • 2\. History of prior axillary nodal surgery
  • 3\. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Indocyanine green (ICG) solution injection

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

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sheri Nichols

(916) 734-7289slnichols@health.ucdavis.edu

Locations

University of California Davis Health

Recruiting

Sacramento, California, United States, 95816

Contacts

Shari Nichols

(916) 734-7289slnichols@health.ucdavis.edu

Principal Investigator:

Ara Salibian, MD

More Information

Sponsor

University of California, Davis

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-01.