NCT06672224

Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema

Prospective Analysis of Patients at Risk for Breast Cancer-Related Lymphedema (BCRL) Using Indocyanine Green (ICG) Fluoroscopy and SPYTM Angiography

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, indocyanine green (ICG), with SPY (Trademark) angiography in breast cancer patients at risk for breast cancer-related lymphedema (BCRL). Patients that are diagnosed with breast cancer with lymph node involvement often undergo treatment that includes surgery to remove the axillary nodes and radiation. Unfortunately, this procedure increases the incidence of BCRL in the surgical arm, as well as other problems including heaviness of the arm, fibrotic skin changes, and an increase in infection risk. Because of these symptoms, venipuncture (blood draw) is often avoided in these arms. Researchers want to show that placement of an IV line and fluid administration in patients at risk for BCRL will indeed not alter the lymphatic structure of the arm and will not change the incidence of BCRL by administering indocyanine green (ICG) dye to patients and assessing their arm lymphatics. ICG is a fluorescent dye that is able to be visualized by the SPY angiography imaging system as it travels through the lymphatic system, allowing researchers to assess how well blood flows throughout the body. Receiving ICG and undergoing SPY angiography may be effective in showing that placement of an IV and fluid administration in breast cancer patients at risk for BCRL will not alter the lymphatic structure of their arm and will not change the incidence of BCRL.

Detailed description

PRIMARY OBJECTIVE: I. Assess the change in lymphatic architecture resulting from placement of an IV line and fluid administration in patients at risk for BCRL. SECONDARY OBJECTIVES: I. Identify changes in presence/severity of lymphedema based on: Ia. SOZO Digital Health Platform scale; Ib. Patient self-reported outcomes; Ic. Arm circumference. II. Assess association between SOZO scale, MD Anderson Cancer Center (MDACC) lymphedema score (LS), and patient-reported outcomes. EXPLORATORY OBJECTIVES: I. Observe changes in mapping of superficial lymphatics that are responsible for the upper extremity arm with use of ICG dye and SPY angiography. II. Identify risk factors associated with higher rates of lymphedema after IV line/fluid administration. OUTLINE: Patients receive ICG dye subcutaneously (SC) and receive fluids IV over one hour and undergo SPY imaging and lymphedema assessment on day 1. Patients also receive ICG dye and undergo imaging and lymphedema assessments again at 1, 3, 6, and 12 months on study.

Conditions

• Breast Cancer-Related Lymphedema
• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Fluid Therapy	Given IV
DRUG	Indocyanine Green	Given subcutaneously
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Research or Clinical Assessment Tool	Undergo lymphedema assessment
PROCEDURE	SPY Elite Fluorescence Imaging	Undergo SPY imaging
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2025-08-14
• Primary completion: 2026-08-14
• Completion: 2026-08-14
• First posted: 2024-11-04
• Last updated: 2025-09-17