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Phase I Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders


N/A
6 Years
N/A
Open (Enrolling)
Both
Lymphedema

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Trial Information

Phase I Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders


Currently, there is no method to assess lymphatic function in subjects with acquired
(following surgery or trauma) or hereditary lymphedema. The causes of hereditary lymphedema
and the means to distinguish between acquired lymphedema is not available from existing
diagnostics. A method to monitor lymphatic function could assist in the development of new
therapies, prediction of subjects with susceptibility to acquire lymphedema, and evaluation
of subjects' conditions. In this Phase I trial, we conduct near-infrared fluorescence
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
the arms and legs of 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.


Inclusion Criteria:



- Agree to blood collection for DNA testing

- Children 6-8 years of age must be able to remain still for imaging

- Both limbs must be present, including 5 fingers or toes/limb

- Subjects with lymphatic dysfunction must be diagnosed with lymphedema, lipedema, or
vascular malformation that suggests a lymphatic component

Exclusion Criteria:

- Nonambulatory subjects

- Pregnancy or breast feeding

- Allergy to iodine

- Weigh more than 400 lb

- Pre-existing skin conditions at injection sites (eczema, rash, scarring, tattoos,
etc.)

- If subject is female of child-bearing potential, must agree to use birth control for
one month after study participation

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Cross-Sectional

Principal Investigator

Eva M Sevick, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston

Authority:

United States: Food and Drug Administration

Study ID:

HSC-IMM-08-0415

NCT ID:

NCT00833599

Start Date:

January 2009

Completion Date:

June 2013

Related Keywords:

  • Lymphedema
  • lymphedema
  • genetic
  • Lymphatic Diseases
  • Lymphedema

Name

Location

Memorial Hermann Hospital Texas Medical Center Lymphedema ClinicHouston, Texas  77030