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Trial record 4 of 4 for:
"Lipedema"
Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
This study is enrolling participants by invitation only.
Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Lymphatic Malformation Institute
Information provided by (Responsible Party):
Eva Sevick, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00833599
First received: January 30, 2009
Last updated: January 14, 2016
Last verified: June 2015
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Purpose
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 lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).
| Condition | Intervention |
|---|---|
| Lymphedema Lymphatic Disorders Lipedema Vascular Malformation Vascular Anomaly | Drug: NIRFLI with ICG |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Phase I/II Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders |
Resource links provided by NLM:
Genetics Home Reference related topics:
Meige disease
Parkes Weber syndrome
capillary malformation-arteriovenous malformation syndrome
lymphedema-distichiasis syndrome
U.S. FDA Resources
Further study details as provided by Eva Sevick, The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- 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 ]
Biospecimen Retention: Samples With DNA
DNA from blood or saliva
| Estimated Enrollment: | 258 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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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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Drug: NIRFLI with ICG
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:
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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.
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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.
Eligibility| Ages Eligible for Study: | 3 Months and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| 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
Criteria
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):
1) The subject has experienced a medical problem from a prior blood draw
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833599
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833599
Locations
| United States, Texas | |
| Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center | |
| Houston, Texas, United States, 77030 | |
| UT Physicians Pediatric Surgery Clinic | |
| Houston, Texas, United States, 77030 | |
| Wound Care Clinic at CHI St. Luke's The Woodland's Hospital | |
| The Woodlands, Texas, United States, 77384 | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Lymphatic Malformation Institute
Investigators
| Principal Investigator: | Eva M Sevick, PhD | The University of Texas Health Science Center, Houston |
More Information
Publications:
| Responsible Party: | Eva Sevick, Professor of Molecular Medicine; Director of Center for Molecular Imaging, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00833599 History of Changes |
| Other Study ID Numbers: |
HSC-IMM-08-0415 R01HL092923 ( U.S. NIH Grant/Contract ) R01CA128919 ( U.S. NIH Grant/Contract ) |
| Study First Received: | January 30, 2009 |
| Last Updated: | January 14, 2016 |
Keywords provided by Eva Sevick, The University of Texas Health Science Center, Houston:
|
Lymphedema Genetic Lymphatic Disorder |
Lipedema Vascular Malformation Vascular Anomaly |
Additional relevant MeSH terms:
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Disease Lymphedema Congenital Abnormalities Vascular Malformations Lipedema |
Lymphatic Diseases Pathologic Processes Cardiovascular Abnormalities Cardiovascular Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on July 14, 2017