Imaging Sodium and Lymphatics in Lymphedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-10

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Visualizing Vascular Mechanisms of Lipedema

NCT05464927

Lipedema

ACTIVE_NOT_RECRUITING

Lymphedema Progression Screening Using MRI

NCT02611557

Lymphedema Breast Cancer

COMPLETED NA

A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.

NCT02154204

Focus of Study is: Near Infrared Fluorescence Imaging

COMPLETED

Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

NCT01412970

Comparison of Availability for Prediction of Volume Responsiveness Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation

WITHDRAWN NA

Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

NCT00833599

Lymphedema Lymphatic Disorders Lipedema +3 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The overall goal of this work is to apply and evaluate novel, noninvasive MRI technologies sensitive to sodium and lymphatic circulation in patients with well-characterized lymphatic disease. The results will clarify mechanisms of lymphatic clearance of tissue sodium, and evaluate novel biomarkers of lymphedema risk, progression, and treatment response. Recent evidence supports that lymphatics regulate interstitial sodium levels. When lymphatic clearance is impaired, hypertonic interstitial sodium results in tissue swelling, skin sodium storage, and poor blood pressure control. When lymphatic clearance is impaired in rodent models of lymphedema, lymph stasis and inflammation ensue, leading to tissue remodeling and fibrosis. These data suggest, but do not confirm, that impaired lymphatic clearance contributes to tissue sodium storage and fibrosis. However, this possibility has not been investigated rigorously owing to a lack of clinically-feasible measurement tools sensitive to sodium and lymphatics in humans. To address these gaps in knowledge, the investigators have developed a noninvasive MR lymphangiography (MRL) approach to quantify lymphatic vasculature in patients with unilateral lymphedema of the upper-extremities. They confirmed lateralized lymph stasis and enlarged lymphatic collector cross-sectional area that reduced following manual lymphatic drainage therapy. In parallel to these studies, the investigators optimized noninvasive sodium 23Na MRI for measurement of tissue sodium content (TSC) in the legs of patients with lymphatic insufficiency due to lipedema. In preliminary data, they demonstrate these methods together for the first time in patients with cancer-related lower-extremity lymphedema (LEL) who display significantly elevated skin TSC compared to controls (24.2±6.8 vs. 14.2±1.8 mmol/L, p\<0.001, effect size Cohen's d=1.2). Evidence of lymphatic impairment on MRL and tissue sodium deposition are differential in patients with increasing disease severity, and modified by lymphatic complete decongestive therapy (CDT), motivating the following hypotheses:

Hypothesis (1): Skin TSC inversely correlates with lymphatic flow velocity; lymphatic flow velocity reduces and TSC increases following LN removal in patients at risk for lymphedema. Hypothesis (2): Skin TSC positively correlates with lymphedema stage; subcutaneous sodium co-localizes with fibrotic tissue in patients with lymphedema and fibrosis. Hypothesis (3): Skin TSC decreases and lymphatic flow velocity increases after CDT in affected limbs with LEL; imaging metrics are reproducible in healthy volunteers. Impact: Results will demonstrate relationships between tissue sodium and lymphatic dysfunction in human disease using noninvasive MRI technologies. This will outline clinically-feasible biomarkers of lymphedema risk, progression, and treatment response which could have significance for future clinical trials that seek to evaluate the impact of emerging lymphatic therapies on tissue sodium storage.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphedema of Leg Lymphedema, Secondary Lymphedema Related Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

At-risk for lymphedema

Participants at-risk for leg lymphedema

Standard imaging protocol

Intervention Type OTHER

The standard imaging protocol entails noninvasive magnetic resonance imaging techniques including sodium and lymphatic angiography.

With lymphedema

Participants with leg lymphedema

Standard imaging protocol

Intervention Type OTHER

The standard imaging protocol entails noninvasive magnetic resonance imaging techniques including sodium and lymphatic angiography.

With lymphedema undergoing complete decongestive therapy (CDT)

Participants with leg lymphedema undergoing routine complete decongestive therapy (CDT)

Complete decongestive therapy

Intervention Type PROCEDURE

The investigators will identify participants undergoing clinically-indicated interventions that they are already receiving for their routine clinical management (complete decongestive physical therapy). They will make no evaluation of the efficacy of these procedures, but rather will test fundamental hypotheses regarding lymphatic clearance of tissue sodium.

Standard imaging protocol

Intervention Type OTHER

The standard imaging protocol entails noninvasive magnetic resonance imaging techniques including sodium and lymphatic angiography.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Complete decongestive therapy

The investigators will identify participants undergoing clinically-indicated interventions that they are already receiving for their routine clinical management (complete decongestive physical therapy). They will make no evaluation of the efficacy of these procedures, but rather will test fundamental hypotheses regarding lymphatic clearance of tissue sodium.

Intervention Type PROCEDURE

Standard imaging protocol

The standard imaging protocol entails noninvasive magnetic resonance imaging techniques including sodium and lymphatic angiography.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

manual lymphatic drainage compression exercise

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No