Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
Public ClinicalTrials.gov record NCT03584633. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT03584633
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 9 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 14, 2019
- Primary completion
- Sep 29, 2019
- Completion
- Dec 30, 2019
- Last update posted
- Dec 26, 2024
2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03584633, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2024 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03584633 live on ClinicalTrials.gov.