A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.

The aim of this study is to examine the use of Near Infrared Fluorescence imaging on lymphatic vessels in humans.

Different parameters that reflect lymphatic function will be tested for intra and inter individual reproducibility.

We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy men between the ages of 20 and 30.

When the fluorescent dye "indocyanine green", has been injected into the skin on the patients feet, it will be transported through the lymph vessels, resulting in clear visualization of the vessels, using a laser and a EM-CCD camera.

On both legs we examine the frequency of vessel contraction and the velocity of lymph moving in vessels. We furthermore use several methods to quantify the vessel function such as the refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and pumping pressure (at what pressure lymph can pass a blood pressure cuff).

We investigate the activity of vessels over time, and after several interventions such as exercise, and water baths of the foot at different temperatures.

The patients are examined for approximately 4 hours and wil be examined again 14 days later.

Study Overview

• Status: Completed
• Conditions: Focus of Study is: Near Infrared Fluorescence Imaging

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of cardiothoracic and vascular surgery, Aarhus university hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The participants are young healthy males.

Description

Inclusion Criteria:

Exclusion Criteria:

• lymphedema, edema or vascular disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of contraction in lymph vessels.	At baseline and after 14 days
Pumping pressure	At baseline and after 14 days
refill time	At baseline and after 14 days
velocity	At baseline and after 14 days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Director: Vibeke E Hjortdal, MD, PhD, DMSc, Department of cardiothoracic and vascular surgery, Aarhus university hospita; Principal Investigator: Jacob H Grønlund, bac. med., Department of cardiothoracic and vascular surgery, Aarhus university hospita

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: NIRF2014