This clinical trial tests the usefulness of indocyanine green dye with ultra-high frequency ultrasound for assessing lymphatic anatomy in patients with breast cancer undergoing axillary lymph node dissection or sentinel lymph node biopsy. Indocyanine green (ICG) is the current clinical standard of care for lymphatic mapping of the arms and legs to identify lymphatic structures (anatomy). Ultrasound is also routinely used for mapping of lymphatic vessels in patients undergoing lymphatic surgery. The difference in this study is that ultrasound with ICG will be used to map healthy lymphatic vessels in subjects without lymphedema to better understand what normal anatomy looks like on ultrasound and evaluate any side effects of ICG.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07677839.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Ara Salibian
Phone: 916-734-7844
PRIMARY OBJECTIVE:
I. Investigate normal lymphatic anatomy in patients with breast cancer using ultra-high frequency ultrasound (UHFUS).
SECONDARY OBJECTIVES:
I. Further investigate normal lymphatic anatomy in patients with breast cancer using UHFUS.
II. To evaluate the adverse reactions to indocyanine green (ICG) dye.
III. Characterize variability in ultrasonographic characteristics of lymphatic channels in patients without lymphedema.
IV. Investigate correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels along defined pathways in patients without lymphedema.
V. Investigate correlation of ICG lymphography patterns and patient demographics.
OUTLINE:
Patients receive ICG via injection and undergo ultra-high frequency ultrasound imaging prior to standard of care axillary lymph node dissection or sentinel lymph node biopsy.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorAra Salibian