Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

• Conditions: Lipedema; Vascular Malformation; Lymphatic Disorders; Lymphedema; Vascular Anomaly; Dercum Disease
• Interventions: Drug: NIRFLI with ICG

• Registration Number: NCT00833599
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-23
• Primary Completion: 2019-12
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1: NIRFLI with ICG	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.

Primary Outcome Measures

Name	Time	Method
Near-infrared fluorescence lymphatic imaging (NIRFLI) provides informaton on lymphatic function or dysfunction to diagnose disorders	Images are collected for up to 3 hours after injection with indocyanine green

Trial Locations

Locations (3)

Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center; 🇺🇸 Houston, Texas, United States

UT Physicians Pediatric Surgery Clinic; 🇺🇸 Houston, Texas, United States

Wound Care Clinic at CHI St. Luke's The Woodland's Hospital; 🇺🇸 The Woodlands, Texas, United States