Phase I/II Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 283
- 试验地点
- 3
- 主要终点
- Near-infrared fluorescence lymphatic imaging (NIRFLI) provides informaton on lymphatic function or dysfunction to diagnose disorders
研究概览
简要总结
The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and other lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).
详细描述
Currently, there is no method to assess lymphatic function in persons with acquired (developed following surgery or trauma) lymphedema, hereditary lymphedema or other lympho-vascular disorders. The causes of these disorders, and the means to distinguish between them, is not available from existing diagnostics. A method to monitor lymphatic function could assist in the development of new therapies, the prediction of a patient's susceptibility to develop these disorders, and the evaluation of patient's conditions or responses to therapy and treatment. In this Phase I/II trial, we inject Indocyanine Green (ICG) off-label as a lymph contrast agent and use a custom designed fluorescence imager to conduct near-infrared fluorescence imaging to dynamically follow lymphatic trafficking in subjects. Blood is also collected for DNA analysis. The resulting images are analyzed, and the phenotypes observed in both normal and diseased subjects are used to correlate to mutations of specific genes reported to be associated with lymphatic development.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Participation in NIRFLI with ICG (Group 1):
- •Negative urine pregnancy test within 36 hours prior to study drug administration, if female of childbearing potential.
- •Females must complete the Female Enrollment Form. Those subjects of childbearing potential must agree to use one of the medically accepted methods of contraception listed on the form for a period of one month following the study. Female subjects of non-childbearing potential, defined as physiologically incapable of becoming pregnant, must meet the criteria listed on the Female Enrollment form, but are not restricted to the use of contraception following study participation.
- •Subjects must be able to lie on their backs for periods of 10 minutes at at time for up to a total of 60 minutes.
- •Children must be able to remain reasonably still for the time required for imaging.
- •Subjects with lymphatic dysfunction must be diagnosed with lymphedema, lipedema, or vascular malformation/anomaly that suggests a lymphatic component.
排除标准
- •for Participation in NIRFLI with ICG (Group 1):
- •Persons with mobililty issues that could make participating too difficult
- •Women who are pregnant or breast-feeding
- •Persons who are allergic to iodine
- •Persons who weigh in excess of 400 lbs
- •If the subject is a female of child-bearing potential, she must agree to use a contraceptive for one month after study participation.
- •Persons who do not meet inclusion criteria.
- •Inclusion Criteria for Participation in Genetic Analysis Only (Group 2):
- •The subject has a family member with lymphatic dysfunction.
- •The subject is willing to have blood drawn or saliva collected for DNA analysis
- •Exclusion Criteria for Participation in Genetic Analysis Only (Group 2):
- •1) The subject has experienced a medical problem from a prior blood draw
研究组 & 干预措施
1: NIRFLI with ICG
1) Persons affected with lymphatic or lympho-vascular disorders, 2) Family members (affected or unaffected) of persons affected with lymphatic or lympho-vascular disorders and 3) Health, normal persons (Controls) that participate at one of the clinical sites in both the lymphatic function imaging with indocyanine green and the Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) system, as well, as the genetic analysis portion of the study.
干预措施: NIRFLI with ICG (Drug)
2: Genetic Analysis Only
Family members of an affected subject from Group 1. Subjects in Group 2 can be either affected or unaffected and will provide a blood or saliva sample for the genetic analysis portion of the study, but will not undergo lymphatic function imaging with ICG and the NIRFLI system. Group 2 individuals are not required to travel to one of the clinical sites in order to participate in the study.
结局指标
主要结局
Near-infrared fluorescence lymphatic imaging (NIRFLI) provides informaton on lymphatic function or dysfunction to diagnose disorders
时间窗: Images are collected for up to 3 hours after injection with indocyanine green
次要结局
未报告次要终点
研究者
Eva Sevick
Professor of Molecular Medicine; Director of Center for Molecular Imaging
The University of Texas Health Science Center, Houston