Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

Summary

Indocyanine Green (ICG) lymphography is a relatively new imaging technique that allows for quick visualization of superficial lymph flow in real-time, without radiation exposure. This imaging is useful for diagnosing and assessing lymphedema. ICG lymphography has a higher sensitivity and specificity than lymphoscintigraphy, the current gold standard imaging device for lymphedema. ICG lymphography precisely and reliably diagnoses, tracks, and stages lymphedema severity, ranging from subclinical or early lymphedema to more advanced cases. The ICG contrast dye used to visualize the lymphatic system takes approximately six hours to plateau. Therefore, patients must wait six hours between their initial and delayed scans.

The purpose of this study is to determine if exercising on a Nu-step device between ICG initial and delayed scans would shorten the period of time a patient had to spend at the hospital on the day of their ICG lymphography.

The general procedures for this involve (after selecting subjects, consenting subjects, educating the subject on the protocol, along with other appropriate measures):

* Taking baseline vitals (HR \& SpO2) and limb circumference measurements
* 5-minute period of time to acquaint subject with the exercise equipment (Nu-Step) at any level of exertion
* injection of contrast agent to allow for visualization of the superficial lymphatic system by a qualified nurse
* Initial scan
* A 5-minute period of exercise at "moderate" level of exercise (This correlates to the rating of perceived exertion levels of 12-13; All exercise periods should be at this level and will be monitored by a provider)
* Second scan \& vitals
* 5-minute period of exercise
* Third scan \& vitals

o Continue 5-minute exercise period followed by scan \& vitals until disease pattern emerges

\* Exercise for 5 minutes then scan and vitals until images reach steady state for two consecutive scans
* Final vitals (HR \& SpO2)

\* Repeat scan every 1 hour until the normal 6 hour scan to monitor for further changes in lymphatic pattern.
* Exit survey

Conditions

• Lymphedema

Interventions

DRUG

Indocyanine Green

The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.

Sponsors & Collaborators

• University of Iowa

  lead OTHER

Principal Investigators

• Wei F Chen, MD, FACS · University of Iowa

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-15

Primary Completion

2019-09-30

Completion

2019-12-31

FDA Drug

Yes

Countries

• United States

Study Locations