Assessment of Lymphatic Structure and Function Pre- and Post- Treatment and During Recovery in Head and Neck Cancer Patients Using NIR Fluorescence Lymphatic Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Lymph Movement Measured by ICG Lymphography.
研究概览
简要总结
Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.
详细描述
A non-randomized, non-blinded, single site pilot study designed to assess whether near-infrared fluorescence imaging can report on the efficacy of a pneumatic compression device to move lymph in head and neck cancer survivors with resulting head and neck lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Participants must be 18 years of age or older
- •Participants must be diagnosed with Lymphedema of the Head and/or Neck
- •Participants must be diagnosed with squamous cell carcinoma of the oral cavity, oropharynx or larynx and underwent surgery and radiation as part of their standard-of-care treatment plan.
- •Participants must be ≥ 4 weeks post-radiation therapy
- •Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration
- •Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session
- •Participants must be willing to use the Flexitouch® System at home daily for two (2) weeks
排除标准
- •Women who are pregnant or breast-feeding
- •Persons who are allergic to iodine
- •A female of child-bearing potential, who does not agree to use an approved contraceptive for one month after study participation
- •Persons who do not meet inclusion criteria
- •Persons with pulmonary edema, thrombophlebitis, congestive heart failure, deep vein thrombosis, episodes of pulmonary embolism, infections and inflammation, or acute cancer
- •Persons with uncontrolled hyperthyroidism or parathyroidism (for with an endocrinologist recommends against neck compression)
- •Carotid sinus hypersensitivity syndrome
- •Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
- •Symptomatic bradycardia in the absence of a pacemaker
- •Internal jugular venous thrombosis, acute or within 3 months
- •Known intracranial pressure or other contraindication to internal or external jugular venous compression
- •Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative
- •Facial or head and neck dermal metastasis
- •Acute facial infection (e.g., facial or parotid gland abscess)
- •Any condition where increased venous and lymphatic return is undesirable
研究组 & 干预措施
Pneumatic Compression-1 session per day
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
干预措施: Head and neck garments for pneumatic compression device (Device)
Pneumatic Compression-1 session per day
Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).
干预措施: NIRFLI with ICG (Drug)
Pneumatic Compression-2 sessions per day
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
干预措施: Head and neck garments for pneumatic compression device (Device)
Pneumatic Compression-2 sessions per day
Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).
干预措施: NIRFLI with ICG (Drug)
结局指标
主要结局
Lymph Movement Measured by ICG Lymphography.
时间窗: Single Treatment, 2 Weeks of Treatment
Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.
次要结局
- Dermal Backflow Measured by ICG Lymphography.(Single Treatment, 2 Weeks of Treatment)
- Symptom Alleviation Measured by Survey Response.(Single Treatment, 2 Weeks of Treatment)
- Ease of Use Measured by Survey Response.(Single Treatment, 2 Weeks of Treatment)