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NCT03584633 · ClinicalTrials.gov registry record · Phase 4
Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
A Phase 4 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT03584633 is a Phase 4 study that has completed, run by University of Iowa. The registered enrollment target is 9 participants.
The verdict
NCT03584633, a Phase 4 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study 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 no
Interventions
- DRUG Indocyanine Green
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03584633
The ClinicalTrials.gov registry entry for NCT03584633 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Indocyanine Green is the first listed.
NCT03584633 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03584633 about?
NCT03584633 is a clinical study titled "Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging". 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...
What is the current status of trial NCT03584633?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2019-04-15. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03584633?
The interventions under investigation include: Indocyanine Green (DRUG).
Who is sponsoring clinical trial NCT03584633?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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