Imaging Sodium and Lymphatics in Lymphedema (NCT05242900) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Imaging Sodium and Lymphatics in Lymphedema
United States75 participantsStarted 2021-10-10
Plain-language summary
Recent evidence supports lymphatic regulation of tissue sodium handling, however fundamental gaps persist in knowledge regarding the role of lymphatics in human diseases of sodium dysregulation. The goal of this work is to apply novel, noninvasive imaging tools to measure relationships between lymphatic function and tissue sodium in patients with well-characterized lymphedema. Findings are intended to inform mechanisms of lymphatic clearance of tissue sodium, and provide novel imaging biomarkers of lymphedema progression and treatment response.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biologically Female
* Age range = 18-80 years
* BMI range = 18 to 40 kg/m2
Exclusion Criteria:
* Primary lymphedema
* Contraindication to 3T MRI
* Pregnant
* Severe claustrophobia
* Inability to provide written, informed consent
* Active infection anywhere in the body, or open wound on the lower-extremities or at locations for measurement
* Subjects who cannot adhere to the experimental protocols for any reason
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of tissue sodium content
Timeframe: Baseline to completion of routine course of physical therapy (approximately 6 weeks)
2
Number of participants that changed lymphedema severity
Timeframe: Baseline to completion of routine course of physical therapy (approximately 6 weeks)
3
Concentration of tissue sodium content baseline
Timeframe: Baseline
4
Quantification of lymphatic states in extremities at baseline