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

Primary Purpose

Lymphedema Arm

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumason
Optison
Definity
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphedema Arm focused on measuring Lymphaticovenous anastomosis surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment. Patient qualifies for LVA surgery as determined by the plastic surgeons performing the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to surgery. Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only). Patients must be able to understand the study procedures and comply with them for the entire length of the study. No contraception is necessary or required. Exclusion Criteria: Pregnant or nursing women. Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.31. Known or suspected cardiac shunts. Prior lymphedema surgery in the upper extremity. Tattoo or scar on either upper extremity. Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Microbubble contrast agent Lumason

Microbubble contrast agent Optison

Microbubble contrast agent Definity

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Lymphatic vessel visualization
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
High-frequency ultrasound and shear-wave elastography
Identify any patent lymphatic channels on CEUS or high-frequency ultrasound that were not detected by the reference standard ICG lymphography. We will additionally measure dermal thickness on B-mode ultrasound and perform SWE at levels comparable to the lymphedema grading metrics routinely collected at surgical visits.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2022
Last Updated
January 13, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05613946
Brief Title
Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema
Acronym
CASTLE
Official Title
Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Part 1 - Evaluate the uptake of microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic visualization by ultrasound. Part 2 - Combine preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. Evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema Arm
Keywords
Lymphaticovenous anastomosis surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microbubble contrast agent Lumason
Arm Type
Other
Arm Description
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.
Arm Title
Microbubble contrast agent Optison
Arm Type
Other
Arm Description
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.
Arm Title
Microbubble contrast agent Definity
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lumason
Other Intervention Name(s)
sulfur hexafluoride lipid-type A microspheres
Intervention Description
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Intervention Type
Drug
Intervention Name(s)
Optison
Other Intervention Name(s)
perflutren protein-type A microspheres
Intervention Description
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Intervention Type
Drug
Intervention Name(s)
Definity
Other Intervention Name(s)
perflutren lipid microsphere
Intervention Description
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
Primary Outcome Measure Information:
Title
Lymphatic vessel visualization
Description
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
Time Frame
5 minutes after injection
Title
High-frequency ultrasound and shear-wave elastography
Description
Identify any patent lymphatic channels on CEUS or high-frequency ultrasound that were not detected by the reference standard ICG lymphography. We will additionally measure dermal thickness on B-mode ultrasound and perform SWE at levels comparable to the lymphedema grading metrics routinely collected at surgical visits.
Time Frame
1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment. Patient qualifies for LVA surgery as determined by the plastic surgeons performing the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to surgery. Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only). Patients must be able to understand the study procedures and comply with them for the entire length of the study. No contraception is necessary or required. Exclusion Criteria: Pregnant or nursing women. Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.31. Known or suspected cardiac shunts. Prior lymphedema surgery in the upper extremity. Tattoo or scar on either upper extremity. Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.. Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Lee, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlyn Pierson, RN, CCRP
Phone
507-538-8706
Email
pierson.karlyn@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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