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Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

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ClinicalTrials.gov Identifier: NCT03584633
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Chen, University of Iowa

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
Time to reach indocyanine green lymphography steady state [ Time Frame: 8 weeks ]
After subjects exercise, this outcome will be measured by indocyanine green lymphography, a non-radioactive scan that visualizes the lymphatic system.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584633 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
Time for initial disease pattern to appear [ Time Frame: 8 weeks ]
After subjects exercise, this outcome will be measured by indocyanine green lymphography scans, a non-radioactive scan that visualizes the lymphatic system
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
Official Title  ICMJE Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment
Brief 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
Detailed Description

Following consent, the patients will answer the questions in the screening questionnaire and this data will be collected. Patients that do not screen out of the study (i.e. meet all inclusion criteria and none of the exclusion criteria) will continue with the study. Individuals who meet the exclusion criteria will not continue.

Study participants will be asked to go to the Rehabilitation Therapies clinic on the lower level of the main hospital for a one time visit. The visit will take approximately three to six hours.

During the visit, height and weight will be measured. Circumference measurements of the arms and legs will also be measured with a measuring tape. Bioimpedance analysis of the limb will be performed to assess the fluid content in the limbs.

Pain Ease numbing spray will have been applied to three injection sites on the affected arm or leg. 0.1ml of 0.25% Indocyanine green (ICG) dye will then be injected into the distal arm or leg at three separate sites: two interdigital injections and one injection in the volar wrist or posterior to the medial malleolus.

An immediate scan will be acquired using an ICG lymphography device. The scan will take approximately five minutes to complete. The data from this image will be considered baseline. This image is part of the patient's normal care at our institution and would be done even if the subject was not in this study.

The participant will then use the Nu-Step exercise machine for five minutes at a rate of perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a pulse oximeter. After five minutes, a delayed scan will be performed with the NOVADAQ SPY Elite System and data will be recorded. The participant will continue to exercise for five minutes at an RPE of 12-13 and be scanned after every five minutes until the scans show no change in lymph pattern after two consecutive scans. The patient will be undergoing scanning and be exercising for a maximum of one hour.

Limb circumference measurements and bioimpedance scans will be repeated after exercise has been completed. The scan will be repeated every 1 hour until the normal 6-hour scan to monitor for further changes in the lymphatic pattern.

A post-intervention questionnaire will then be provided to the participant to complete discussing their exercise experience that day during the study, their previous ICG experiences, and their preference between this protocol and the current scanning process.

During the study, the subject will be told when he/she is being photographed/recorded. The injections and scans are clinically-indicated and would occur whether the individual was in the study or not. The initial and last scans are clinically indicated to determine disease status. 3) clarify how the follow-up survey is completed via email

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lymphedema
Intervention  ICMJE 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.
Other Name: NOVADAQ SPY Elite System Indocyanine Green Lymphography
Study Arms  ICMJE Lymphedema
The subjects with lymphedema 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 Indocyanine Green Lymphography.
Intervention: Drug: Indocyanine Green
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients
  • Suspected lymphedema or previously diagnosed lymphedema
  • Between the ages of 18-85 years old.

Exclusion Criteria:

  • Allergies to iodine
  • pregnant
  • nursing
  • On daily heart medication
  • Have medical conditions affecting the heart, lungs or joint conditions that prevent prolonged physical activity of the arms or legs.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584633
Other Study ID Numbers  ICMJE 201803867
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wei Chen, University of Iowa
Study Sponsor  ICMJE Wei Chen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei F Chen, MD, FACS University of Iowa
PRS Account University of Iowa
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP