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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL092923 | U.S. NIH Grant/Contract | View source | |
| R01CA128919 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Cancer Institute (NCI) | NIH |
| Lymphatic Malformation Institute | OTHER |
| Lipedema Foundation |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for Participation in NIRFLI with ICG (Group 1):
Exclusion Criteria for Participation in NIRFLI with ICG (Group 1):
Inclusion Criteria for Participation in Genetic Analysis Only (Group 2):
Exclusion Criteria for Participation in Genetic Analysis Only (Group 2):
1) The subject has experienced a medical problem from a prior blood draw
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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
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| Name | Affiliation | Role |
|---|---|---|
| Eva M Sevick, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center | Houston | Texas | 77030 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19233639 | Background | 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. | |
| 28623992 | Derived | 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. |
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| OTHER |
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DNA from blood or saliva
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| UT Physicians Pediatric Surgery Clinic |
| Houston |
| Texas |
| 77030 |
| United States |
| Wound Care Clinic at CHI St. Luke's The Woodland's Hospital | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D008206 | Lymphatic Diseases |
| D065134 | Lipedema |
| D054079 | Vascular Malformations |
| D000274 | Adiposis Dolorosa |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008068 | Lipomatosis |
| D012871 | Skin Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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