Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders (NCT00833599) | Clinical Trial Compass
By InvitationNot Applicable
Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders
United States283 participantsStarted 2009-01
Plain-language 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 disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).
Who can participate
Age range3 Months
SexALL
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Inclusion criteria
✓. 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
✕. 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.
What they're measuring
1
Near-infrared fluorescence lymphatic imaging (NIRFLI) provides informaton on lymphatic function or dysfunction to diagnose disorders
Timeframe: Images are collected for up to 3 hours after injection with indocyanine green
Trial details
NCT IDNCT00833599
SponsorThe University of Texas Health Science Center, Houston