Lymphedema ArmPhase 1CASTLENCT05613946
Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema
A Phase 1 study testing Lumason, Optison and Definity in people with Lymphedema Arm, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema Arm
- What is being tested?
- Lumason, Optison and Definity
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 30 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study
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.
Read the 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.
- Conditions
- Lymphedema Arm
- Being tested
- Lumason, Optison, Definity
- Keywords
- Lymphaticovenous anastomosis surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumasonDrug
Also called sulfur hexafluoride lipid-type A microspheres
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
OptisonDrug
Also called perflutren protein-type A microspheres
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
DefinityDrug
Also called perflutren lipid microsphere
Ultrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity
| Study group | Role | What they receive |
|---|---|---|
| Microbubble contrast agent Lumason | Other | 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. Receives: Drug: Lumason |
| Microbubble contrast agent Optison | Other | 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. Receives: Drug: Optison |
| Microbubble contrast agent Definity | Other | 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. Receives: Drug: Definity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes after injection
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.
Measured: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start15 Dec 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine U. Lee, Mayo Clinic
- Investigators
- Christine Lee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613946
- Sponsor's protocol ID
- 22-006006
- Acronym
- CASTLE
- Status last verified
- Aug 2024
- First submitted
- 4 Nov 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema (CASTLE) Study
- ClinicalTrials.gov ID
- NCT05613946
- Acronym / sponsor ID
- CASTLE / 22-006006
- Conditions
- Lymphedema Arm
- Keywords
- Lymphaticovenous anastomosis surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microbubble contrast agent Lumason | Other | Drug: LumasonWhile subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound. |
| Microbubble contrast agent Optison | Other | Drug: OptisonWhile subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound. |
| Microbubble contrast agent Definity | Other | Drug: DefinityWhile subjects are undergoing standard of operation for arm with lymphedema, the healthy arm will receive intradermal injection of microbubbles and imaged immediately by ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumasonAlso: sulfur hexafluoride lipid-type A microspheresUltrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity | Drug | Microbubble contrast agent Lumason |
| OptisonAlso: perflutren protein-type A microspheresUltrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity | Drug | Microbubble contrast agent Optison |
| DefinityAlso: perflutren lipid microsphereUltrasound microbubble contrast agent intradermal 0.2-0.3 cc of microbubble suspension per injection, 10-12 total injections per upper extremity | Drug | Microbubble contrast agent Definity |
Primary outcome
Lymphatic vessel visualization
Time frame: 5 minutes after injection
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
Time frame: 1.5 hours for intraoperative CEUS and out-patient SWE both at baseline and 6-month follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Lymphatic Mapping with Contrast-Enhanced Ultrasound (manuscript)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Lee, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lumason, Optison and Definity in people with Lymphedema Arm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphatic vessel visualization (time frame: 5 minutes after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.