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Diagnostic Imaging Techniques for Lymphedema (CASTLE Trial)

Phase 1
Recruiting
Led By Christine Lee, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment.
Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 hours for intraoperative ceus and out-patient swe both at baseline and 6-month follow-up
Awards & highlights

CASTLE Trial Summary

This trial will compare 3 microbubble agents for lymphatic visualization, to help plan for surgery and measure response to treatment.

Who is the study for?
This trial is for individuals with unilateral lymphedema in the upper extremity (stage 2 or 3) due to breast cancer or its treatment. Candidates must qualify for LVA surgery, agree to it, and be able to attend a follow-up after 6 months. Pregnant women, those allergic to microbubble agents or certain proteins, and people with prior lymphedema surgery are excluded.Check my eligibility
What is being tested?
The study aims to identify the best microbubble agent (Lumason®, Optison®, Definity®) for visualizing lymphatic channels via ultrasound. It also assesses how well high-frequency B-mode ultrasound helps pre-surgery planning and if shear wave elastography can track treatment progress at a half-year mark.See study design
What are the potential side effects?
Potential side effects may include allergic reactions related to hypersensitivity towards microbubble contrast agents like Lumason®, Optison®, Definity® as well as ingredients such as albumin and PEG. Specific side effect profiles of each agent will be monitored.

CASTLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have swelling in one arm due to breast cancer or its treatment.
Select...
I have swelling in one arm due to breast cancer or its treatment.
Select...
I am approved for LVA surgery by Dr. Tran or Dr. Fahradyan and agree to the surgery.
Select...
I can attend a follow-up appointment in 6 months.
Select...
I have swelling in one arm due to breast cancer or its treatment.

CASTLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 hours for intraoperative ceus and out-patient swe both at baseline and 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 hours for intraoperative ceus and out-patient swe both at baseline and 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
High-frequency ultrasound and shear-wave elastography
Lymphatic vessel visualization

CASTLE Trial Design

3Treatment groups
Experimental Treatment
Group I: Microbubble contrast agent OptisonExperimental Treatment1 Intervention
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.
Group II: Microbubble contrast agent LumasonExperimental Treatment1 Intervention
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.
Group III: Microbubble contrast agent DefinityExperimental Treatment1 Intervention
While subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumason
2015
Completed Phase 4
~390
Optison
2002
Completed Phase 4
~150
Definity
2007
Completed Phase 4
~520

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,287 Total Patients Enrolled
5 Trials studying Lymphedema
569 Patients Enrolled for Lymphedema
Christine Lee, MD, PhDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Microbubble contrast agent Lumason Clinical Trial Eligibility Overview. Trial Name: NCT05613946 — Phase 1
Lymphedema Research Study Groups: Microbubble contrast agent Lumason, Microbubble contrast agent Optison, Microbubble contrast agent Definity
Lymphedema Clinical Trial 2023: Microbubble contrast agent Lumason Highlights & Side Effects. Trial Name: NCT05613946 — Phase 1
Microbubble contrast agent Lumason 2023 Treatment Timeline for Medical Study. Trial Name: NCT05613946 — Phase 1
Lymphedema Patient Testimony for trial: Trial Name: NCT05613946 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapy been granted regulatory authorization by the FDA?

"Due to the Phase 1 nature of this trial, our team at Power has assigned a score of 1 in regards to safety, as there is only limited data supporting its efficacy and security."

Answered by AI

Is enrollment for this investigation still an option?

"Clinicaltrials.gov records reveal that this particular research project is no longer recruiting patients, as it was posted on December 15th 2022 and its most recent update occured November 4th 2022. Nevertheless, there are still 76 other medical trials actively seeking participants at present."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I’m really not happy that there isn’t more available for treatment options. As a cancer survivor, this is a daily reminder of my losses.
PatientReceived no prior treatments
~11 spots leftby Mar 2025