Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema
- Conditions
- Breast Cancer-Related LymphedemaBreast Carcinoma
- Interventions
- Procedure: Fluid TherapyOther: Questionnaire AdministrationOther: Research or Clinical Assessment ToolProcedure: SPY Elite Fluorescence ImagingOther: Survey Administration
- Registration Number
- NCT06672224
- Lead Sponsor
- City of Hope Medical Center
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
-
Documented written informed consent of the participant
-
Men or women age: >= 18 years
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Diagnosis of breast cancer
-
Full axillary dissection at least 12 months prior
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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
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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
- Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency
- Diagnosis of lymphedema
- Women of childbearing potential: pregnant/nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive Care (ICG, fluid, SPY, lymphedema assessment) Fluid Therapy 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. Supportive Care (ICG, fluid, SPY, lymphedema assessment) Questionnaire Administration 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. Supportive Care (ICG, fluid, SPY, lymphedema assessment) Indocyanine Green 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. Supportive Care (ICG, fluid, SPY, lymphedema assessment) Research or Clinical Assessment Tool 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. Supportive Care (ICG, fluid, SPY, lymphedema assessment) SPY Elite Fluorescence Imaging 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. Supportive Care (ICG, fluid, SPY, lymphedema assessment) Survey Administration 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
City of Hope Medical Center
🇺🇸Duarte, California, United States