Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00833599|
Recruitment Status : Unknown
Verified May 2018 by Eva Sevick, The University of Texas Health Science Center, Houston.
Recruitment status was: Enrolling by invitation
First Posted : February 2, 2009
Last Update Posted : May 23, 2018
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Lymphedema Lymphatic Disorders Lipedema Vascular Malformation Vascular Anomaly Dercum Disease||Drug: NIRFLI with ICG|
|Study Type :||Observational|
|Estimated Enrollment :||283 participants|
|Official Title:||Phase I/II Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
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
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.
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.
- 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
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, Learn About Clinical Studies.
|Ages Eligible for Study:||3 Months and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833599
|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|
|Principal Investigator:||Eva M Sevick, PhD||The University of Texas Health Science Center, Houston|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eva Sevick, Professor of Molecular Medicine; Director of Center for Molecular Imaging, The University of Texas Health Science Center, Houston|
|Other Study ID Numbers:||
R01HL092923 ( U.S. NIH Grant/Contract )
R01CA128919 ( U.S. NIH Grant/Contract )
|First Posted:||February 2, 2009 Key Record Dates|
|Last Update Posted:||May 23, 2018|
|Last Verified:||May 2018|
Connective Tissue Diseases
Lipid Metabolism Disorders