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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Lymphatic Malformation Institute
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 16, 2015
Last verified: June 2015
  Purpose

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 lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).


Condition Intervention
Lymphedema
Lymphatic Disorders
Lipedema
Vascular Malformation
Vascular Anomaly
Drug: NIRFLI with ICG

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA from blood or saliva


Estimated Enrollment: 258
Study Start Date: January 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Names:
  • IC-Green
  • Cardio-Green
  • ICG
  • Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
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.

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 causes of these disorders, and the means to distinguish between them, is not available from existing diagnostics. A method to monitor lymphatic function could assist in the development of new therapies, the prediction of a patient's susceptibility to develop these disorders, and the evaluation of patient's conditions or responses to therapy and treatment. In this Phase I/II trial, we inject Indocyanine Green (ICG) off-label as a lymph contrast agent and use a custom designed fluorescence imager to conduct near-infrared fluorescence imaging to dynamically follow lymphatic trafficking in subjects. Blood is also collected for DNA analysis. The resulting images are analyzed, and the phenotypes observed in both normal and diseased subjects are used to correlate to mutations of specific genes reported to be associated with lymphatic development.

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

1) Persons with lymphatic dysfunction (e.g. lymphedema, lipedema, dercums, etc.), 2) Persons with vascular malformation that suggest a lymphatic component, 3) Family members of persons, whom participated in this study, with a lymphatic dysfunction or vascular malformation that suggests a lymphatic component and 3) Healthy, normal individuals as controls

Criteria

Inclusion Criteria for Participation in NIRFLI with ICG (Group 1):

  1. Negative urine pregnancy test within 36 hours prior to study drug administration, if female of childbearing potential.
  2. 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.
  3. 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.
  4. Children must be able to remain reasonably still for the time required for imaging.
  5. 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):

  1. Persons with mobililty issues that could make participating too difficult
  2. Women who are pregnant or breast-feeding
  3. Persons who are allergic to iodine
  4. Persons who weigh in excess of 400 lbs
  5. If the subject is a female of child-bearing potential, she must agree to use a contraceptive for one month after study participation.
  6. Persons who do not meet inclusion criteria.

Inclusion Criteria for Participation in Genetic Analysis Only (Group 2):

  1. The subject has a family member with lymphatic dysfunction.
  2. 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

  Contacts and Locations
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, see Learn About Clinical Studies.

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

Contacts
Contact: John R Morrow, BS 713-500-3562 John.R.Morrow@uth.tmc.edu
Contact: Eva M Sevick, PhD 713-500-3561 Eva.Sevick@uth.tmc.edu

Locations
United States, Texas
Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: John R Morrow, BS    713-500-3562    John.R.Morrow@uth.tmc.edu   
UT Physicians Pediatric Surgery Clinic Enrolling by invitation
Houston, Texas, United States, 77030
Wound Care Clinic at CHI St. Luke's The Woodland's Hospital Recruiting
The Woodlands, Texas, United States, 77384
Contact: John R. Morrow, BS    713-500-3562    John.R.Morrow@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Lymphatic Malformation Institute
Investigators
Principal Investigator: Eva M Sevick, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:
Responsible Party: Eva Sevick, Professor of Molecular Medicine; Director of Center for 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 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Lymphedema
Genetic
Lymphatic Disorder
Lipedema
Vascular Malformation
Vascular Anomaly

Additional relevant MeSH terms:
Congenital Abnormalities
Lymphatic Diseases
Lymphedema
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 05, 2015