跳至主要内容
临床试验/NCT06672224
NCT06672224撤回不适用

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

City of Hope Medical Center0 个研究点目标入组 50 人开始时间: 2025年8月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
50
主要终点
Percentage of patients with worsening lymphedema in the affected arm

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: Fluid Therapy (Procedure)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: Indocyanine Green (Drug)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: Questionnaire Administration (Other)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: Research or Clinical Assessment Tool (Other)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: SPY Elite Fluorescence Imaging (Procedure)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Experimental

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.

干预措施: Survey Administration (Other)

结局指标

主要结局

Percentage of patients with worsening lymphedema in the affected arm

时间窗: 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.

次要结局

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

研究者

发起方
City of Hope Medical Center
申办方类型
Other
责任方
Sponsor

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