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

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).

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Key information

Conditions

Lymphedema Adiposis Dolorosa Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Dercum Disease Hemic and Lymphatic Diseases Lipedema Lipid Metabolism Disorders Lipomatosis Lymphatic Diseases Lymphatic Disorders Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases Vascular Anomaly Vascular Malformation Vascular Malformations

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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):

The subject has experienced a medical problem from a prior blood draw

Treatment and study plan

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.

Other names: IC-Green, Cardio-Green, ICG, Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

Lipedema Foundation
Lymphatic Malformation Institute
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Phase I/II Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

Important dates

Study start: 2009
Primary completion: 2030
Study completion: 2030
First posted: Feb 2, 2009
Registry last updated: Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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