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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT00833599
Status
Enrolling By Invitation

Conditions

  • Dercum Disease
  • Lipedema
  • Lymphatic Disorders
  • Lymphedema
  • Vascular Anomaly
  • Vascular Malformation

Eligibility Criteria

Sex
ALL
Age
3 Months - N/A
Healthy Volunteers
Accepted

Interventions

  • NIRFLI with ICG — DRUG
    We conduct Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic trafficking in subjects. We seek to use the resulting phenotypes acquired in normal and diseased patients to correlate to mutations of specific genes reported to be associated with lymphatic development.

Study Details

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).

Key Dates

Start date
Jan 31, 2009
Status verified
Mar 2026
Primary completion
Dec 1, 2030
Completion
Dec 1, 2030

Study Design

Enrollment
283 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical CenterHoustonTexas77030-
UT Physicians Pediatric Surgery ClinicHoustonTexas77030-
Wound Care Clinic at CHI St. Luke's The Woodland's HospitalThe WoodlandsTexas77384-

Find similar trials in Houston, TX

By research site
Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center· Houston, TXUT Physicians Pediatric Surgery Clinic· Houston, TXWound Care Clinic at CHI St. Luke's The Woodland's Hospital· The Woodlands, TX

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