Status:
UNKNOWN
Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Conditions:
Lymphedema
Lymphatic Disorders
Eligibility:
All Genders
3+ years
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...
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00833599
Start Date
January 1 2009
End Date
June 1 2020
Last Update
May 23 2018
Active Locations (3)
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1
Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center
Houston, Texas, United States, 77030
2
UT Physicians Pediatric Surgery Clinic
Houston, Texas, United States, 77030
3
Wound Care Clinic at CHI St. Luke's The Woodland's Hospital
The Woodlands, Texas, United States, 77384