Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Ara Salibian, MD (ucdavis)

Description

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.

Official Title

Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer

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. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.

The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.

Keywords

Breast Cancer, Breast Neoplasms, Indocyanine Green, Solutions, Indocyanine green (ICG) solution injection, Ultra-High Frequency Ultrasound

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Location

  • University of California Davis Health accepting new patients
    Sacramento California 95816 United States

Lead Scientist at University of California Health

  • Ara Salibian, MD (ucdavis)
    Associate Professor, Med: Surgery, School of Medicine. Authored (or co-authored) 88 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT07677839
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated