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Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

This study is currently recruiting participants.
Verified June 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
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: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging of subjects with acquired and hereditary lymphedema and lymphovascular disorders and to attempt to correlate imaging phenotype with genotype. Normal and diseased volunteers are evaluated.


Condition Intervention
Lymphedema
 Drug: near-infrared fluorescence imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Phase I Combinational Investigational New Drug Application: Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Biospecimen Retention:   Samples With DNA

DNA from blood or saliva


Estimated Enrollment: 208
Study Start Date: January 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Persons with Grade I or Grade II lymphedema
 Drug: near-infrared fluorescence imaging
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.
2
Control group
 Drug: near-infrared fluorescence imaging
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Persons with lymphatic dysfunction

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833599

Contacts
Contact: Karen M Gore, BS 7135003435 Karen.M.Gore@uth.tmc.edu
Contact: Eva M Sevick, PhD 7135003561 Eva.Sevick@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital Texas Medical Center Lymphedema Clinic Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eva M Sevick, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:

Responsible Party: Eva Sevick, Professor - IMM, 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, R01CA128919
Study First Received: January 30, 2009
Last Updated: June 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
lymphedema
genetic

Additional relevant MeSH terms:
Lymphatic Diseases
Lymphedema

ClinicalTrials.gov processed this record on May 22, 2013