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

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.

• Fluid Therapy (Procedure): Given IV
• Indocyanine Green (Drug), also known as ICG: Given subcutaneously
• Questionnaire Administration (Other): Ancillary studies
• Research or Clinical Assessment Tool (Other), also known as Clinical Assessment Tool, Clinical or Research Assessment Tool: Undergo lymphedema assessment
• SPY Elite Fluorescence Imaging (Procedure), also known as SPY Elite, SPY Elite Imaging: Undergo SPY imaging
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Percentage of patients with worsening lymphedema in the affected arm [Baseline to 12 months]: 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.

Secondary outcomes

• Change in lymphedema severity based on SOZO Digital Health Platform scale [Baseline to 12 months]: 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.
• Change in patient self-reported outcomes scores [Baseline to 12 months]: 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.
• Change in arm circumference measurements [Baseline to 12 months]: 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.
• Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference [Baseline to 12 months]: 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.

Sex: All, ages: 18 Years to any

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

• Jeff Chang, Principal investigator, City of Hope Medical Center

NIH grants: P30CA033572