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

Focus of Study is: Near Infrared Fluorescence Imaging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154204
• Other study ID #: NIRF2014
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: June 28, 2017
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• lymphedema, edema or vascular disease.

Related Conditions & MeSH terms

• Focus of Study is: Near Infrared Fluorescence Imaging

Locations

Country	Name	City	State
Denmark	Department of cardiothoracic and vascular surgery, Aarhus university hospital.	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of contraction in lymph vessels.		At baseline and after 14 days
Primary	Pumping pressure		At baseline and after 14 days
Primary	refill time		At baseline and after 14 days
Primary	velocity		At baseline and after 14 days