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

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Carcinoma; Breast Cancer-Related Lymphedema
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Procedure: Fluid Therapy; Drug: Indocyanine Green; Other: Research or Clinical Assessment Tool; Procedure: SPY Elite Fluorescence Imaging

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented written informed consent of the participant
• Men or women age: >= 18 years
• Diagnosis of breast cancer
• Full axillary dissection at least 12 months prior
• Patient needs vena puncture and has problem with access in the contralateral arm. Recruitment includes patients who do not wish to use their contralateral arm, lower extremities, or central access through their neck, as well as patients for whom multiple attempts result in increased anxiety, discomfort, and treatment delays
• No clinical evidence of lymphedema by MD Anderson grading system and normal SOZO values compared to contralateral arm

• Willingness to:

  • Complete Lymphedema Life Impact Scale (LLIS) survey
  • Allow measurement of arm circumference, bioimpedance, and ICG imaging in real time
  • Permit medical record/clinical laboratory result review

Exclusion Criteria:

• Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency
• Diagnosis of lymphedema
• Women of childbearing potential: pregnant/nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Care (ICG, fluid, SPY, lymphedema assessment); Patients receive ICG dye 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.

Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Procedure: Fluid Therapy; Given IV; Drug: Indocyanine Green; Given subcutaneously; Other Names: ICG; Other: Research or Clinical Assessment Tool; Undergo lymphedema assessment; Other Names: Clinical Assessment Tool; Clinical or Research Assessment Tool; Procedure: SPY Elite Fluorescence Imaging; Undergo SPY imaging; Other Names: SPY Elite; SPY Elite Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with worsening lymphedema in the affected arm	Measured by the MD Anderson Cancer Center (MDACC) lymphedema score (LS) (measured on a scale of 0 to 5) increased by at least 1 level. Will be estimated as a percentage of patients with MDACC lymphedema score that is at least 1 unit worse at 12 months than at baseline; 95% confidence interval (CI) will be calculated.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lymphedema severity based on SOZO Digital Health Platform scale	Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.	Baseline to 12 months
Change in patient self-reported outcomes scores	Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.	Baseline to 12 months
Change in arm circumference measurements	Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.	Baseline to 12 months
Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference	Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeff Chang, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 14, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema; Breast Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Therapy; Indoles; Fluid Therapy; Indocyanine Green
• Other Study ID Numbers: 23823 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2024-08855 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No