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NCT05613946 · ClinicalTrials.gov registry record · Phase 1

Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT05613946: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT05613946 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT05613946, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Primary Outcome

The time from injection to lymphatic visualization, the duration of contrast visualization, and the longest length of lymphatic channel visualized for each injection site will be determined

Interventions

  • DRUG Lumason
  • DRUG Optison
  • DRUG Definity

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2022-12-15
Est. Completion 2024-06-30
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT05613946 record still lists

NCT05613946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 3 interventions - of which Lumason is the first listed.

NCT05613946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05613946 about?

NCT05613946 is a clinical study titled "Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema". The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for pres...

What is the current status of trial NCT05613946?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-12-15. Estimated completion is 2024-06-30.

What interventions are being tested in trial NCT05613946?

The interventions under investigation include: Lumason (DRUG), Optison (DRUG), Definity (DRUG).

Who is sponsoring clinical trial NCT05613946?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05613946's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05613946, the US trial registry maintained by the National Library of Medicine. NCT05613946 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.