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

NCT00833599 | Enrolling By Invitation

• 3 other identifiers: HSC-IMM-08-0415R01HL092923R01CA128919
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

Lymphedema; Genetic; Lymphatic Disorder; Lipedema; Vascular Malformation; Vascular Anomaly; Dercum Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Drug: NIRFLI with ICG

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.

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.

Also known as: IC-Green, Cardio-Green, ICG, Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

1: NIRFLI with ICG

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\) Persons with lymphatic dysfunction (e.g. lymphedema, lipedema, dercums, etc.), 2) Persons with vascular malformation that suggest a lymphatic component, 3) Family members of persons, whom participated in this study, with a lymphatic dysfunction or vascular malformation that suggests a lymphatic component and 3) Healthy, normal individuals as controls

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The subject has a family member with lymphatic dysfunction.
• The subject is willing to have blood drawn or saliva collected for DNA analysis
• \) The subject has experienced a medical problem from a prior blood draw

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Cancer Institute (NCI): collaborator
• Lymphatic Malformation Institute: collaborator
• Lipedema Foundation: collaborator
• The University of Texas Health Science Center, Houston: lead

Study Sites (3)

Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center

Houston, Texas, 77030, United States

Location

UT Physicians Pediatric Surgery Clinic

Houston, Texas, 77030, United States

Location

Wound Care Clinic at CHI St. Luke's The Woodland's Hospital

The Woodlands, Texas, 77384, United States

Location

Related Publications (2)

• Rasmussen JC, Tan IC, Marshall MV, Fife CE, Sevick-Muraca EM. Lymphatic imaging in humans with near-infrared fluorescence. Curr Opin Biotechnol. 2009 Feb;20(1):74-82. doi: 10.1016/j.copbio.2009.01.009. Epub 2009 Feb 23.

  PMID: 19233639 BACKGROUND

• Rasmussen JC, Zvavanjanja RC, Aldrich MB, Greives MR, Sevick-Muraca EM. Near-infrared fluorescence lymphatic imaging of Klippel-Trenaunay syndrome. J Vasc Surg Venous Lymphat Disord. 2017 Jul;5(4):533-537. doi: 10.1016/j.jvsv.2017.01.011.

  PMID: 28623992 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood or saliva

MeSH Terms

Conditions

Lymphedema; Lymphatic Diseases; Lipedema; Vascular Malformations; Adiposis Dolorosa

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipomatosis; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Eva M Sevick, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Molecular Medicine; Director of Center for Molecular Imaging

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: January 1, 2009
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (3)